MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-09 for MIND + BODY CARE HEW3000 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[174325111]
Kaz usa, inc. Has requested that the product be returned to our company for testing, but it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[174325112]
A consumer stated that she had allegedly received third degree burns on her side while using a heating pad, and medical attention was later sought for her injuries. The consumer stated that this incident occurred while she was sleeping with the heating pad, and she initially thought that she had shingles. The instructions for proper use clearly state "do not use this wrap while sleeping". Kaz usa, inc. Has requested that the product be returned to our company for testing.
Patient Sequence No: 1, Text Type: D, B5
[180521144]
A consumer stated that she had allegedly received third degree burns on her side while using a heating pad, and medical attention was later sought for her injuries. The consumer stated that this incident occurred while she was sleeping with the heating pad, and she initially thought that she had shingles. The instructions for proper use clearly state "do not use this wrap while sleeping".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2020-00003 |
| MDR Report Key | 9569752 |
| Report Source | CONSUMER |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2016-11-12 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONJA WILKINSON |
| Manufacturer Street | 400 DONALD LYNCH BOULEVARD SUITE 300 |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5084907236 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIND + BODY CARE |
| Generic Name | WRAPAROUND? ELECTRIC SPA WRAP |
| Product Code | IRT |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2020-01-22 |
| Model Number | HEW3000 |
| Lot Number | 31516GMT |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC., A HELEN OF TROY COMPANY |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2020-01-09 |