MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-03-05 for HOMEDICS PARASPA MINI PAR-100 NA manufactured by Kwonnie Electrical Products Ltd..
[807939]
Prn-fail perform specs - burn hole in unit. No complaint received with unit, it was returned to our customer (the retailer) for exchange or refund.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832894-2008-00002 |
| MDR Report Key | 1007254 |
| Report Source | 08 |
| Date Received | 2008-03-05 |
| Date of Report | 2008-03-04 |
| Date of Event | 2008-03-04 |
| Date Facility Aware | 2008-03-04 |
| Report Date | 2008-03-04 |
| Date Reported to Mfgr | 2008-03-05 |
| Date Mfgr Received | 2008-03-04 |
| Date Added to Maude | 2008-05-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DIANE ZALAC |
| Manufacturer Street | 3000 PONTIAC TRAIL C-0000440 |
| Manufacturer City | COMMERCE TOWNSHIP MI 48390 |
| Manufacturer Country | US |
| Manufacturer Postal | 48390 |
| Manufacturer Phone | 2488633000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMEDICS PARASPA MINI |
| Generic Name | PARAFFIN BATH |
| Product Code | IMC |
| Date Received | 2008-03-05 |
| Model Number | PAR-100 |
| Catalog Number | NA |
| Lot Number | 2906 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2.5 YR |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1004607 |
| Manufacturer | KWONNIE ELECTRICAL PRODUCTS LTD. |
| Manufacturer Address | KOWLOON HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-05 |