MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-09-15 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra, York - Imiltex.
[16726624]
"customer reported the item is not glued properly". Based upon one previous serious injury reported with a similar device, found in a two year look back, there is the potential for harm to a pt.
Patient Sequence No: 1, Text Type: D, B5
[17045304]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00061 |
| MDR Report Key | 2270591 |
| Report Source | 05,08 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-09-15 |
| Date Mfgr Received | 2011-08-17 |
| Date Added to Maude | 2012-06-26 |
| 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 | 2011-09-15 |
| Catalog Number | 67723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - IMILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-15 |