MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-04 for NU-GAUZE IODOFORM PACKING SLIP manufactured by Johnson & Johnson.
[14089]
The rptr has stopped using the product because he has not received a satisfactory answer from the mfr as to why 20 years of being yellow in color the product is now white. He would like to know if the product contains iodoform and whether or not he can rely on it being bacteriostatic. The rptr stated that there was no indication on the label that the color of the product had been changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000678 |
| MDR Report Key | 21615 |
| Date Received | 1995-04-04 |
| Date of Report | 1994-06-14 |
| Date Added to Maude | 1995-05-03 |
| 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-GAUZE IODOFORM PACKING SLIP |
| Generic Name | PACKING STRIP |
| Product Code | GEL |
| Date Received | 1995-04-04 |
| Lot Number | 291071 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21657 |
| Manufacturer | JOHNSON & JOHNSON |
| Manufacturer Address | NEW BRUNSWICK NJ 08903 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-04 |