MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-07-02 for 5 CS MIRR FS DOUBLE SIDE 67-720 manufactured by Integra York, Pa Inc.
[2682870]
Customer reports that the mirror did pop out in the pt's mouth, they easily retrieved the mirror, there was no pt injury. The event occurred within the past month. No details available.
Patient Sequence No: 1, Text Type: D, B5
[10001585]
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 | 2523190-2012-00059 |
| MDR Report Key | 2645172 |
| Report Source | 06 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-07-02 |
| Date Mfgr Received | 2012-06-25 |
| Date Added to Maude | 2012-10-22 |
| 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 | 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 | 5 CS MIRR FS DOUBLE SIDE |
| Generic Name | M52 - HYGIENE/PERIODONTAL |
| Product Code | EAX |
| Date Received | 2012-07-02 |
| Catalog Number | 67-720 |
| 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 | 2012-07-02 |