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How to interpret requirements for MDR?
I work for a medical device company, and our distributor sends us a complaint regarding a vascular port.
There is not much information available on the complaint.
Patient develops a rash, one week after implantation of a vascular port, at the site of the port. Patient was referred to a dematologist. Cause of rash is unknown. Nothing more is reported
Several attempts were conducted to get info....nothing more
There is no indication of device malfunction or injury reoccuring if device were to malfunction again. I guess seeing a dermatologist would be some sort of intervention. There is so far a single incident
Is this a MDR reportable? How would FDA view this?
In most cases, should the conservative approach of filing a MDR be the answer.
All advice and suggestion is welcomed.
thanks
I work for a medical device company, and our distributor sends us a complaint regarding a vascular port.
There is not much information available on the complaint.
Patient develops a rash, one week after implantation of a vascular port, at the site of the port. Patient was referred to a dematologist. Cause of rash is unknown. Nothing more is reported
Several attempts were conducted to get info....nothing more
There is no indication of device malfunction or injury reoccuring if device were to malfunction again. I guess seeing a dermatologist would be some sort of intervention. There is so far a single incident
Is this a MDR reportable? How would FDA view this?
In most cases, should the conservative approach of filing a MDR be the answer.
All advice and suggestion is welcomed.
thanks



Great point Amigo,
Here why I am not in agreement with Qara - "a combination of the device and the surgical procedure may have caused problem". What about the possibility that the procedure (or how it was performed) is the cause of this problem? Why should we close the door on potential doctor/nurse mistake? My point is that if the device is NOT source of Contamination, - it should not be responsible for the surgical procedure or how it was performed!
and the link is: