MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-10 for MIR- #5, PLANE, CS SCH HENRY SCHEIN 1001404 manufactured by Integra York, Pa Inc..
[3545236]
Dental mirror fell apart in patient's mouth and was swallowed. On (b)(6) 2013 dentist reports he was filing a tooth when the mirror fell out of it's frame on (b)(6) 2013. Patient immediately went to urgent care for an x-ray and the dentist believes and endoscopy was performed to remove the mirror the next day. Dentist is not aware of any harm to patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10837592]
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 | 2523190-2013-00029 |
| MDR Report Key | 3164290 |
| Report Source | 06 |
| Date Received | 2013-06-10 |
| Date of Report | 2013-06-10 |
| Date of Event | 2013-05-13 |
| Date Mfgr Received | 2013-05-20 |
| Date Added to Maude | 2013-06-13 |
| 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 | DENTIST |
| 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 | MIR- #5, PLANE, CS SCH HENRY SCHEIN |
| Generic Name | M52 - HYGIENE/ PERIODONTAL |
| Product Code | EAX |
| Date Received | 2013-06-10 |
| Catalog Number | 1001404 |
| Lot Number | 49504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2013-06-10 |