MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-02 for BRAUN IRT-3520 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[145790501]
Kaz usa, inc. Has requested that the product be returned to our company for testing, but it has not yet been received. This device was manufactured approximately 10 years ago.
Patient Sequence No: 1, Text Type: N, H10
[145790502]
A consumer reported that her thermometer had allegedly given false negative readings on her infant for several days, and this may have caused a delay in medical attention. The device allegedly gave a reading that was 3. 5? F lower than what was measured at their pediatrician. There were no complications from this incident, and the patient is doing well now. Kaz usa, inc. Has requested that the product be returned to our company for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00027 |
| MDR Report Key | 8574452 |
| Report Source | CONSUMER |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-05-02 |
| 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 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 | EAR THERMOMETER |
| Product Code | FLL |
| Date Received | 2019-05-02 |
| Model Number | IRT-3520 |
| Lot Number | LOT 9500387916100206 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-02 |