MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2012-02-02 for MICRO MIR 5MM OVAL CS FS 017-24801 manufactured by Integra York, Pa Inc..
[2534416]
On (b)(6) 2012 the dental assistant reported during an apicoectomy the dentist was using the micro-mirror inside the pt's mouth. There was no protective device in place during the procedure. When the dentist handed the mirror back to the dental assistant, the assistant noticed the mirror head was missing; there was no pt injury or issues reported and the dental assistant reported she 'assumed the pt swallowed the mirror".
Patient Sequence No: 1, Text Type: D, B5
[9632761]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00015 |
| MDR Report Key | 2449877 |
| Report Source | 05,06,08 |
| Date Received | 2012-02-02 |
| Date of Report | 2012-02-02 |
| Date Mfgr Received | 2012-01-27 |
| Date Added to Maude | 2012-08-14 |
| 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 FENANDEZ |
| 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 | MICRO MIR 5MM OVAL CS FS |
| Generic Name | M50 - ENDODONTICS |
| Product Code | EAX |
| Date Received | 2012-02-02 |
| Catalog Number | 017-24801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-02-02 |