MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for WELL AT WALGREENS 366440 manufactured by Big Wall Enterprises.
[70375426]
The customer reported that she bought a heating wrap from a (b)(6) store about a year ago. She put the heating wrap in her microwave and set the allotted time and removed it. The customer did not feel it was warm enough so she put it back in the microwave for more time and then put it on her shoulder. She said stuff from the wrap was heating her back, chest and wrist. She reported that she went to the er, and followed up with the doctor who indicated that the burn should heal without any further issues. The customer does not have a upc or wic. We do not have information to confirm the allegations as there is not proof that the item was purchased at any (b)(6) store, the customer does not have any wic number that can be tied to our products. Based on the information provided, we assume it was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1460851-2017-00008 |
| MDR Report Key | 6418730 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-02-28 |
| Date Facility Aware | 2017-02-28 |
| Report Date | 2017-02-20 |
| Date Reported to FDA | 2017-02-20 |
| Date Reported to Mfgr | 2017-03-01 |
| Date Added to Maude | 2017-03-20 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | WELL AT WALGREENS |
| Generic Name | HOT / COLD CLAY WRAP BACK |
| Product Code | IMA |
| Date Received | 2017-03-20 |
| Catalog Number | 366440 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIG WALL ENTERPRISES |
| Manufacturer Address | 155 W. 55TH ST. SUITE 200 CLARENDON HILLS IL 60514 US 60514 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-20 |