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-120 UNK manufactured by Kwonnie Electrical Products, Ltd..
[21397175]
Consumer used the product on his hands and feet. When awoke the follwoing day, hands and feet were burned and swollen. Consumer is disabled and suffers from chronic pancreatitis.
Patient Sequence No: 1, Text Type: D, B5
[21473274]
Response to fda 483 for co inspection 12/2006. The inspection of the product determined it is possible that with the consumers existing health condition and soaking in the wax longer than 1 to 2 seconds could have accidentally caused his own burns. Patient was hospitalized for accompanying fever related to pancreatitis and unrelated to 2nd degree burns, which were treated with ointment and wrapped.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1832894-2006-00007 |
| MDR Report Key | 827797 |
| Report Source | 04 |
| Date Received | 2007-02-27 |
| Date of Report | 2006-12-29 |
| Date of Event | 2002-01-27 |
| Date Facility Aware | 2002-02-05 |
| Report Date | 2006-12-29 |
| Date Mfgr Received | 2002-02-05 |
| 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 | 2002-05-30 |
| Model Number | PAR-120 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 815202 |
| Manufacturer | KWONNIE ELECTRICAL PRODUCTS, LTD. |
| Manufacturer Address | * KOWLOON HK |
| Baseline Brand Name | HOMEDICS |
| Baseline Generic Name | PARAFFIN BATH |
| Baseline Model No | PAR-120 |
| Baseline Catalog No | UNK |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-02-27 |