MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-11 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York Pa Inc.
[18853442]
Customer's initial report: mirrors are falling apart and breaking in pt mouths. On (b)(6) 2013 customer has no clear recollection to pinpoint the event. No harm to pt, pieces retrieved without difficulty.
Patient Sequence No: 1, Text Type: D, B5
[19215671]
To date, the device involved in the reported incident has not been rec'd for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00045 |
| MDR Report Key | 3227268 |
| Report Source | 06 |
| Date Received | 2013-07-11 |
| Date of Report | 2013-07-11 |
| Date Mfgr Received | 2013-06-26 |
| Date Added to Maude | 2013-10-01 |
| 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 | MIRROR - DBL SIDED, SZ 5 |
| Generic Name | M52 - HYGIENE/PERIODONTAL |
| Product Code | EAX |
| Date Received | 2013-07-11 |
| Catalog Number | 67723 |
| Lot Number | UNK |
| 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 | 2013-07-11 |