MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 1998-07-28 for NU GAUZE PACKING STRIP/IODOFORM 8756 manufactured by Johnson & Johnson Medical, Inc..
[121897]
A consumer states that his wife had a lump surgically removed from her breast about two months ago and the wound was left open. The wound was packed with a packing strip. His wife states there was a burning sensation. He stated that a hematoma developed which required debridement. The packing strip was switched to a different type and the wound is doing better. He is unsure of any permanent damage or injury to the wound. His wife is allergic to iodine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-1998-00164 |
| MDR Report Key | 179183 |
| Report Source | 00,04 |
| Date Received | 1998-07-28 |
| Date of Report | 1998-06-30 |
| Date of Event | 1998-06-01 |
| Date Mfgr Received | 1998-06-30 |
| Date Added to Maude | 1998-07-29 |
| 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 | NU GAUZE PACKING STRIP/IODOFORM |
| Generic Name | GAUZE, SPONGE, MEDICATED |
| Product Code | GEL |
| Date Received | 1998-07-28 |
| Model Number | NA |
| Catalog Number | 8756 |
| Lot Number | 599-56 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174225 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL, INC. |
| 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 | 8756 |
| 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. Required No Informationntervention | 1998-07-28 |