MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-05-10 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Inc.
[2650716]
Doctor reported via phone that the mirror fell off in the pt's mouth and was retrieved but could have been swallowed, no pt harm.
Patient Sequence No: 1, Text Type: D, B5
[9849377]
The device involved in the reported incident 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 | 2523190-2012-00049 |
| MDR Report Key | 2577552 |
| Report Source | 08 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-10 |
| Date Mfgr Received | 2012-04-30 |
| Date Added to Maude | 2012-09-20 |
| 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 | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| 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 | 2012-05-10 |
| Catalog Number | 67723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-05-10 |