MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-07 for 5 CS MIRR. FS DOUBLE SIDE 67-720 manufactured by Integra, York - Imiltex.
[22122964]
Facility reported the mirrors are coming apart. On (b)(6) 2011, add'l info was provided by the dental hygienist who reported she used the mirror to pull the pt's cheek back while cleaning the pt's teeth and the mirror slid off into the pt's mouth. She said she felt the adhesive did not hold the mirror securely. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[22130444]
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 | 2523190-2011-00049 |
| MDR Report Key | 2180778 |
| Report Source | 06 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-07-07 |
| Date Mfgr Received | 2011-06-27 |
| Date Added to Maude | 2012-05-21 |
| 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 DRIVE |
| 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 | 5 CS MIRR. FS DOUBLE SIDE |
| Generic Name | M52 - HYGIENE / PERIODONTAL |
| Product Code | EAX |
| Date Received | 2011-07-07 |
| Catalog Number | 67-720 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2011-07-07 |