MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-03-28 for NU-GAUZE PACKING STRIPS/IODOFORM 8755 manufactured by Johnson & Johnson Medical, Inc.
[52651]
Had allergenic type reaction to iodoform packing strips. Exact size (product number ) not known. Required return trip to doctor's office for packing strip removal, which seemed to slowly resolve symptoms. Nurse stated that the packing strip was cause of reaction. Packing strip was replaced with plain packing strips, without apparent return of or increase in symptoms. Pt related the symptoms to be strange taste in mouth and tongue swelling. Called dr's office and was told to come in right away. Did not require hospitalization or any medications.
Patient Sequence No: 1, Text Type: D, B5
[7769878]
No lot number or sample provided for evaluation. The most recent complaint trends show no unexplained upward trends for this product relative to the reported complaint category. No further action will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1618732-1997-00047 |
| MDR Report Key | 78961 |
| Report Source | 04 |
| Date Received | 1997-03-28 |
| Date of Report | 1997-02-27 |
| Date of Event | 1996-09-01 |
| Date Facility Aware | 1997-02-27 |
| Report Date | 1997-03-27 |
| Date Mfgr Received | 1997-02-27 |
| Date Added to Maude | 1997-03-31 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NU-GAUZE PACKING STRIPS/IODOFORM |
| Generic Name | * |
| Product Code | GEL |
| Date Received | 1997-03-28 |
| Model Number | NA |
| Catalog Number | 8755 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 78567 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL, INC |
| Manufacturer Address | 2500 ARBROOK RD 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 | 8755 |
| 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. Life Threatening; 2. Required No Informationntervention | 1997-03-28 |