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 PAR-200 UNK manufactured by Kwonnie Electrical Products, Ltd..
[585534]
Consumer is a diabetic and used the product on her left foot, causing it to become black and swollen. The foot was amputated due to the gangrene infection after the injury.
Patient Sequence No: 1, Text Type: D, B5
[7820147]
Response to fda 783 for inspection 12/2006. The inspection of the product determined it is performing well and within recommended specifications. The wax used is hypoallergenic and does not contain scents or dyes that could irritate sensitive skin. Daughter and grandson used paraffin bath first with no problems. It is more probable that the 10 year pre-existing diabetic condition of the user was the cause of gangrene and not the 4 or 5 times that the unit has been used as stated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1832894-2006-00008 |
| MDR Report Key | 827784 |
| Report Source | 04 |
| Date Received | 2007-02-27 |
| Date of Report | 2006-12-29 |
| Date of Event | 2002-06-09 |
| Date Facility Aware | 2002-06-25 |
| Report Date | 2006-12-29 |
| Date Mfgr Received | 2002-06-25 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2007-03-16 |
| 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 | PARAFFIN BATH |
| Product Code | IMC |
| Date Received | 2007-02-27 |
| Returned To Mfg | 2002-08-06 |
| Model Number | PAR-200 |
| Catalog Number | UNK |
| Lot Number | 0602 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 815189 |
| Manufacturer | KWONNIE ELECTRICAL PRODUCTS, LTD. |
| Manufacturer Address | * KOWLOON HK |
| Baseline Brand Name | HOMEDICS |
| Baseline Generic Name | PARAFFIN BATH |
| Baseline Model No | PAR-200 |
| Baseline Catalog No | UNK |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2007-02-27 |