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 PAR50 UNK manufactured by Kwonnie Electrical Products, Ltd..
[20192580]
Dipped hands in parafin bath and her hands turned red and skin blistered. A few days later, she repeated the process and her hands turned red and blistered. Some skin peeled.
Patient Sequence No: 1, Text Type: D, B5
[20452219]
Response to fda 483 homedics inspection 12/2006. No additional information regarding injuries were rec'd from customer. Product not received from store for evaluation. Replacement given at consumer's request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1832894-2006-00032 |
| MDR Report Key | 890632 |
| Report Source | 04 |
| Date Received | 2007-02-27 |
| Date of Report | 2006-12-29 |
| Date of Event | 2001-12-11 |
| Date Facility Aware | 2001-12-11 |
| Report Date | 2006-12-29 |
| 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 | RL |
| 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 | PAR50 |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 867859 |
| Manufacturer | KWONNIE ELECTRICAL PRODUCTS, LTD. |
| Manufacturer Address | * KOWLOON HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-27 |