MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2012-03-21 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Pa Inc.
[2595207]
The dental hygienist reported the device came apart inside a pt's mouth and was thrown away by the dr. There was no injury reported. The mirror that fell apart inside a pt's mouth was not available for investigation. Two add'l (same) device's "started to lift" and were put on the shelf so they would not be used on pts.
Patient Sequence No: 1, Text Type: D, B5
[9841734]
The device involved in the reported incident was discarded and is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00028 |
| MDR Report Key | 2505122 |
| Report Source | 05,06,07,08 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-03-21 |
| Date Mfgr Received | 2012-03-14 |
| Date Added to Maude | 2012-09-04 |
| 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 | 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 | 2012-03-21 |
| Catalog Number | 67723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-03-21 |