MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2011-12-21 for PHILIPS SONICARE, UV SANITIZER manufactured by Philips Oral Healthcare.
[2400883]
Customer claims that the light on the uv sanitizer popped up and cut his younger brother on the cheek. Customer stated that they took their brother to the doctor and that the small cut just needed to be "patched up".
Patient Sequence No: 1, Text Type: D, B5
[9682234]
On (b)(4) 2011, contact phone number provided by consumer is not in service. Sent a letter, as well as an email, to the consumer in effort to gather more info on the incident and to request that the unit be returned for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3026630-2011-00002 |
| MDR Report Key | 2395300 |
| Report Source | 04,07 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-12-21 |
| Date of Event | 2011-11-21 |
| Date Mfgr Received | 2011-11-21 |
| Date Added to Maude | 2012-07-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TODD BANDY, SR. MGR QUALITY SY |
| Manufacturer Street | BOTHELL EVERETT HWY 22100 BLDG A |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS SONICARE, UV SANITIZER |
| Generic Name | NONE |
| Product Code | NOB |
| Date Received | 2011-12-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ORAL HEALTHCARE |
| Manufacturer Address | BOTHELL WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-21 |