MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-13 for VICKS V912US manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[138688336]
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
[138688337]
A consumer reported that she left her child unattended, to make breakfast for 30 minutes, during which time the child was left to play with the thermometer. According to the consumer, the child chewed on the cover of the thermometer "like a lollipop", and somehow opened the cover of the unit. In the process, the child removed the battery and accidentally swallowed it. The battery caused burns to the esophagus, and the child underwent several surgeries to repair damage to his esophagus from the incident. More medical intervention may be required. The instructions for use have clear warnings which state, "do not allow children to take their temperature unattended", "keep out of reach of young children, elderly and pets", as well as a clear instruction to "carefully replace the battery cover and, using a coin, tighten the cover". It is unclear to us how a securely tightened battery compartment could have been opened by a small child. Kaz usa, inc. Has requested that the product be returned for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2019-00015 |
| MDR Report Key | 8417166 |
| Report Source | CONSUMER |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-24 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-13 |
| 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 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5084907236 |
| Manufacturer G1 | MICROLIFE CORP. |
| Manufacturer Street | 9F, 431, RUIGUANG ROAD, NEIHU |
| Manufacturer City | TAIPEI DISTRICT, TAIWAN CHINA, 11492 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 11492 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICKS |
| Generic Name | DIGITAL THERMOMETER |
| Product Code | FLL |
| Date Received | 2019-03-13 |
| Model Number | V912US |
| Lot Number | UNKNOWN |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2019-03-13 |