MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-30 for BED BUDDY BBF5085-12 manufactured by .
[83988636]
A user returned the hot & cold back wrap - the user complained that it had burned her back. The user showed the store floor leader the burns, in which she took pictures of, and left in the store's office, along with the product. No further response was received regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00107 |
| MDR Report Key | 6830894 |
| Date Received | 2017-08-30 |
| Date of Report | 2017-08-30 |
| Date Facility Aware | 2017-08-01 |
| Report Date | 2017-08-30 |
| Date Reported to FDA | 2017-08-30 |
| Date Added to Maude | 2017-08-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BED BUDDY |
| Generic Name | HOT & COLD BACK WRAP |
| Product Code | IME |
| Date Received | 2017-08-30 |
| Model Number | BBF5085-12 |
| Catalog Number | BBF5085-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-30 |