MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-20 for LAVA * manufactured by R.g. Barry Corp..
[18598082]
The consumer put the wrap in a microwave and then placed it on his bed. A short time later, he noticed the outside cover was turning black and the inner part was burning. He extinguished the fire with water. The consumer believes a broken piece of a sewing needle was left in the wrap during mfg. After heating the wrap in the microwave, the metal piece heated and ignited the contents of the wrap. The material in the "energy pack" is wheat berry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001770 |
| MDR Report Key | 70099 |
| Date Received | 1997-02-20 |
| Date of Report | 1997-02-05 |
| Date Added to Maude | 1997-02-24 |
| 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 | LAVA |
| Generic Name | MICROWAVE HEATED NECK WRAP |
| Product Code | IMA |
| Date Received | 1997-02-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 70023 |
| Manufacturer | R.G. BARRY CORP. |
| Manufacturer Address | 13405 YARMOUTH RD PICKERINGTON OH 43147 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-20 |