MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-06 for REM POLYHESIVE II * E7507 manufactured by Valleylab.
[1524493]
The patient had a total of 6 grounding pads applied. One grounding pad for argon beam coagulation was placed on the right upper back during a surgical procedure. When the pads were removed, staff did not observe redness or blisters on any of the 6 sites. The patient did not report any pain. Two days later, red/purple slough and small blisters were observed on right upper back. Silvadene was given to the patient. The pads are disposable and were disposed since no problems were observed in the operating room. There have been no previously reported problems with the pads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1656467 |
| MDR Report Key | 1656467 |
| Date Received | 2010-04-06 |
| Date of Report | 2010-04-06 |
| Date of Event | 2010-03-19 |
| Report Date | 2010-04-06 |
| Date Reported to FDA | 2010-04-06 |
| Date Added to Maude | 2010-04-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REM POLYHESIVE II |
| Generic Name | GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2010-04-06 |
| Model Number | * |
| Catalog Number | E7507 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALLEYLAB |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-06 |