MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-07-09 for NU GAUZE PACKING STRIP/IODOFORM 8756 manufactured by Johnson & Johnson Medical, Inc..
[223080]
The consumer reported their dr had prescribed a dressing for their cut/wound located on their leg. The prescribed dressing was unavailable and the pharmacist had recommended the packing strips. The consumer reported experiencing extreme burning after applying the packing strip. They continued use of the product and developed blisters. The consumer denied any known sensitivities. The consumer reports they must have a "skin graph".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-2001-00057 |
| MDR Report Key | 341090 |
| Report Source | 04 |
| Date Received | 2001-07-09 |
| Date of Report | 2001-07-06 |
| Date of Event | 2001-06-07 |
| Date Mfgr Received | 2001-06-07 |
| Date Added to Maude | 2001-07-12 |
| 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 |
| Manufacturer Contact | THOM CREEL MANAGER |
| Manufacturer Street | 2500 E. ARBROOK BLVD. |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8172624453 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2001-07-09 |
| Returned To Mfg | 2001-06-15 |
| Model Number | NA |
| Catalog Number | 8756 |
| Lot Number | 2659Y2; 665-56 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 330417 |
| 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. Other | 2001-07-09 |