MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-02-02 for NO GAUZE PACKING STRIP/IODOFORM 8757 manufactured by Johnson & Johnson Medical.
[154107]
She had an infected abdominal incision after a cesarean section. She was discharged to home with a home care agency. Her doctor ordered her wound to be packed with plain packing strips soaked in a solution. This was a continuation of what was being done in the hospital prior to discharge. The home care agency was responsible for providing her supplies. They brought her the packing strips with iodoform. This product was used for one week and caused discomfort and burns to the tissue. The pt followed up with her doctor and use of the product was discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-1999-00016 |
| MDR Report Key | 208267 |
| Report Source | 04 |
| Date Received | 1999-02-02 |
| Date of Report | 1999-01-05 |
| Date Mfgr Received | 1999-01-05 |
| Date Added to Maude | 1999-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NO GAUZE PACKING STRIP/IODOFORM |
| Generic Name | GAUZE, SPONGE, MEDICATED |
| Product Code | GEL |
| Date Received | 1999-02-02 |
| Model Number | NA |
| Catalog Number | 8757 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 202146 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL |
| Manufacturer Address | 2500 ARBROOK BLVD ARLINGTON TX 760143899 US |
| Baseline Brand Name | NU-GAUZE PACKING STRIP/IODOFORM |
| Baseline Generic Name | IODOFORM GAUZE PACKING STRIPS |
| Baseline Model No | * |
| Baseline Catalog No | 8757 |
| Baseline ID | * |
| Baseline Device Family | NU-GAUZE GAUZE SPONGES/PACKING STRIPS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-02 |