MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-03 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Pa Inc..
[2514385]
On (b)(6) 2012, the dental hygienist reported numerous mirrors have fallen apart recently and the staff has been discarding them into the trash. She stated one of the mirror surfaces became unglued and fell into a patient's mouth while the hygienist was using it to view a lingual surface of a tooth. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[9621575]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00001 |
| MDR Report Key | 2431946 |
| Report Source | 05,06 |
| Date Received | 2012-01-03 |
| Date of Report | 2012-01-03 |
| Date Mfgr Received | 2011-12-19 |
| Date Added to Maude | 2012-07-30 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRROR - DBL SIDED, SZ 5 |
| Generic Name | M52 - HYGIENE / PERIODONTAL |
| Product Code | EAX |
| Date Received | 2012-01-03 |
| Catalog Number | 67723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-03 |