MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-15 for COLGATE MOTION BATTERY POWERED TOOTHBRUSH manufactured by Hi-p (xiamen) Precision Plastic Manufacturing Co.,.
[28911842]
Initial information was received on (b)(4) 2015 from a consumer's mother. This (b)(6) year-old male child used a colgate motion battery powered toothbrush and the "very top circular head" came off and lodged in his throat, causing him to choke. He began using the toothbrush twice daily for the first time about six weeks prior to this report, on approximately (b)(6) 2015. Subsequently, he experienced the events on (b)(6) 2015. The moment the choking began, his mother turned him upside down and hit his back and the piece came out. A healthcare professional was not consulted and no treatment was required. He had used the toothbrush with no problems until (b)(6) 2015. The toothbrush was discontinued on (b)(6) 2015. At the time of this report, the child had recovered. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005607635-2015-00013 |
| MDR Report Key | 5153731 |
| Date Received | 2015-10-15 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-02 |
| Date Mfgr Received | 2015-10-05 |
| Date Added to Maude | 2015-10-15 |
| 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 Street | EXPORT PROCESSING ZONE, NO. 5 XINGGANG RD, HAICANG DISTRICT |
| Manufacturer City | XIAMEN, 361026 |
| Manufacturer Country | CH |
| Manufacturer Postal | 361026 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLGATE MOTION BATTERY POWERED TOOTHBRUSH |
| Generic Name | COLGATE MOTION BATTERY POWERED TOOTHBRUSH |
| Product Code | MMD |
| Date Received | 2015-10-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO., |
| Manufacturer Address | EXPORT PROCESSING ZONE, NO. 5, XINGGANG RD, HAICANG DISTRICT XIAMEN, 361026 CH 361026 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-15 |