MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-08 for JOHNSON AND JOHNSON FIRST AID KIT UNK manufactured by Johnson & Johnson Consumer Products Inc..
[19776152]
Rptr purchased the product approx 2 weeks ago. The kit contains plastic tweezers. In order to sterilize the tweezers, according to the rptr, the instructions state to boil them in water or heat in a flame. No time limit is stated in the instructions. Prior to attempting the sterilization process, the rptr called the co seeking further guidance. He was advised that the plastic tweezers were "heat proof". The rptr then attempted the recommended sterilization process by placing the tweezers in the flame from his lighter. The tweezers immediately caught on fire. The rptr called the co again this time to report what had occurred. He was advised that the kit he had purchased was intended for home use and the outdoor kits contain metal tweezers which can be sterilized as described in the instructions. The rptr stated that upon investigation the outdoor kits were found to contain the plastic tweezers that were in the kit he purchased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012753 |
| MDR Report Key | 142031 |
| Date Received | 1998-01-08 |
| Date of Report | 1998-01-08 |
| Date of Event | 1997-12-01 |
| Date Added to Maude | 1998-01-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | JOHNSON AND JOHNSON FIRST AID KIT |
| Generic Name | TWEEZERS |
| Product Code | LRR |
| Date Received | 1998-01-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 138563 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER PRODUCTS INC. |
| Manufacturer Address | US. RT. 1 NORTH BRUNSWICK NJ 08903 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-08 |