MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-30 for BRAUN FHT1000 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
| Report Number | 1314800-2020-00008 |
| MDR Report Key | 9647988 |
| Report Source | CONSUMER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2020-01-30 |
| 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 | SONJA WILKINSON |
| Manufacturer Street | 400 DONALD LYNCH BOULEVARD SUITE 300 |
| Manufacturer City | MARLBOROUGH, MA 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 | BRAUN |
| Generic Name | FOREHEAD THERMOMETER |
| Product Code | FLL |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2020-02-10 |
| Model Number | FHT1000 |
| Lot Number | 32013ONB |
| 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 MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Other; 3. Required No Informationntervention | 2020-01-30 |