MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-15 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Miltex, Inc..
[2731009]
Mirrors popped out. No pt injury. On (b)(6) 2012 customer reports the pt could have swallowed the mirrors but did not. The customer was unable to single out a particular pt or procedure.
Patient Sequence No: 1, Text Type: D, B5
[9921105]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00054 |
| MDR Report Key | 2623524 |
| Report Source | 06 |
| Date Received | 2012-06-15 |
| Date of Report | 2012-06-15 |
| Date Mfgr Received | 2012-06-04 |
| Date Added to Maude | 2012-10-11 |
| 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 | 0 |
| 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 | 2012-06-15 |
| Catalog Number | 67723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTEX, INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-15 |