MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-27 for HOMEDICS PAR250 UNK manufactured by Kwonnie Electrical Products, Ltd..
[19492168]
No user injuries. Thermal protection circuit failed and the unit "overheated to the point of nearly melting the base. "
Patient Sequence No: 1, Text Type: D, B5
[19745353]
Response to fda 483 for homedics insepction 12/2006.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1832894-2006-00035 |
| MDR Report Key | 890637 |
| Report Source | 04 |
| Date Received | 2007-02-27 |
| Date of Report | 2006-12-29 |
| Date of Event | 2001-10-26 |
| Date Facility Aware | 2001-10-26 |
| Date Added to Maude | 2007-08-08 |
| 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 | 3 |
| Manufacturer Contact | DAVE VANDERLIN |
| Manufacturer Street | 3000 PONTIAC TRAIL |
| Manufacturer City | COMMERCE TWP. MI 48390 |
| Manufacturer Country | US |
| Manufacturer Postal | 48390 |
| Manufacturer Phone | 2488633000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMEDICS |
| Generic Name | PARAFIN BATH |
| Product Code | IMC |
| Date Received | 2007-02-27 |
| Model Number | PAR250 |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 867871 |
| Manufacturer | KWONNIE ELECTRICAL PRODUCTS, LTD. |
| Manufacturer Address | * KOWLOON HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-27 |