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 PAR200 UNK manufactured by Kwonnie Electrical Products, Ltd..
[694529]
No user injuries. Wax leaked from paraffin bath damaging area rug.
Patient Sequence No: 1, Text Type: D, B5
[7809878]
Response to fda 483 homedics inspection 12/2006. Evaluation determined stress fracture in bottom of parafin bath caused by extreme pressure such as stepping into bath unit; instead of dipping hand/foot into bath briefly. Damage during use was confirmed by crack revealing used wax seeping through confirming unit was intact when first used ruling out factory defect or shipping damage, as new wax would have leaked when first used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1832894-2006-00034 |
| MDR Report Key | 890168 |
| Report Source | 04 |
| Date Received | 2007-02-27 |
| Date of Report | 2006-12-29 |
| Date of Event | 2001-04-30 |
| Date Facility Aware | 2001-04-30 |
| Date Mfgr Received | 2001-04-30 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2007-08-07 |
| 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 BATCH |
| Product Code | IMC |
| Date Received | 2007-02-27 |
| Returned To Mfg | 2001-07-17 |
| Model Number | PAR200 |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 867623 |
| Manufacturer | KWONNIE ELECTRICAL PRODUCTS, LTD. |
| Manufacturer Address | * KOWLOON HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-27 |