MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-18 for VIBRACARE PERCUSSOR G5 125 manufactured by General Physiotherapy, Inc..
[37121]
Percussor left under pt's back causing device to over heat and burn pt's back. Burn required ointment and dressing. 7cm x 6cm 2nd and 3rd degree.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 58226 |
| MDR Report Key | 58226 |
| Date Received | 1996-12-18 |
| Date of Report | 1996-12-05 |
| Date of Event | 1996-12-04 |
| Date Facility Aware | 1996-12-04 |
| Report Date | 1996-12-05 |
| Date Reported to FDA | 1996-12-16 |
| Date Reported to Mfgr | 1996-12-05 |
| Date Added to Maude | 1996-12-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIBRACARE PERCUSSOR |
| Generic Name | PERCUSSOR |
| Product Code | IRO |
| Date Received | 1996-12-18 |
| Model Number | G5 |
| Catalog Number | 125 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58701 |
| Manufacturer | GENERAL PHYSIOTHERAPY, INC. |
| Manufacturer Address | 13222 LAKEFRONT DR ST LOUIS MO 630451504 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1996-12-18 |