MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-05-09 for ACE HEAT THERAPY PATCH 207535 manufactured by Becton Dickinson.
[839590]
Consumer called and stated that her daughter received a burn from using the ace heat therapy patch on her back. Initial and subsequent contact from the consumer indicates that no medical attention was needed, however, photos returned (2008) indicate a possible 2nd degree burn.
Patient Sequence No: 1, Text Type: D, B5
[8003911]
Eval summary: eval date/time: 2008, 11:49:110. Rc received (2) sealed ace heat therapy patches (low ru 23y), ex 2010 04) from lot reported and one empty wrapper for ace large heat therapy patch which consumer reports receiving a nasty burn. Product has been forwarded to the quality assurance dept for further review. Capa has been opened and reassigned for further investigation. Regulatory compliance will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243072-2008-00026 |
| MDR Report Key | 1047396 |
| Report Source | 04 |
| Date Received | 2008-05-09 |
| Date of Report | 2008-05-07 |
| Date of Event | 2008-03-21 |
| Date Mfgr Received | 2008-04-15 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2009-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SALLY THOMSON |
| Manufacturer Street | 1 BECTON DR. |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018474838 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE HEAT THERAPY PATCH |
| Generic Name | HEAT THERAPY PATCH |
| Product Code | OMW |
| Date Received | 2008-05-09 |
| Returned To Mfg | 2008-04-09 |
| Model Number | NA |
| Catalog Number | 207535 |
| Lot Number | RU23Y |
| ID Number | NA |
| Device Expiration Date | 2010-04-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | ONE BECTON DR. FRANKLIN LAKES NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-09 |