MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-12 for NU-GEL DRESSING 3.75 X 3.75 * 2497 manufactured by Johnson & Johnson Medical Division Of Ethicon Inc..
[283285]
During mri, pt developed warmth then burning under right breast. Pt had dressing with gel-pad for skin breakdown. Immediately removed from scanner. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
[301398]
Add'l info received from mfr 6/30/03: device involved in reported incident was discarded and unavailable for evaluation including any laboratory testing or failure analysis. Therefore no conclusions could be reached in regards to device failure. Due diligence follow-up was conducted with reporter and it was determined that nu-gel dressing was removed from pt approx 10-15 minutes into the mri procedure due to the heat sensation. The rn who removed the dressing did not feel that the dressing was "hot" when removed. The pt required no medical intervention as a result of this incident. Ethicon has not received any add'l complaints similar to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027836 |
| MDR Report Key | 447997 |
| Date Received | 2003-03-12 |
| Date of Report | 2003-02-25 |
| Date of Event | 2003-02-07 |
| Date Added to Maude | 2003-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NU-GEL DRESSING 3.75 X 3.75 |
| Generic Name | DRESSING |
| Product Code | MGQ |
| Date Received | 2003-03-12 |
| Model Number | * |
| Catalog Number | 2497 |
| Lot Number | * |
| ID Number | 3.75 X 3.75 DSG |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 436964 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL DIVISION OF ETHICON INC. |
| Manufacturer Address | * ARLINGTON TX 760043130 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-12 |