MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-06-15 for MOUTH PROP - BLACK, MED 700601-1509-001 manufactured by Integra York, Pa Inc.
[5944024]
Customer initially reports a pt bit through mouth prop and chipped crowns on teeth. On (b)(6) 2015 customer reports that the pt bit through the device and broke a crown. No further info available.
Patient Sequence No: 1, Text Type: D, B5
[13366303]
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
[62391318]
On 06/25/2015 integra investigation completed. Method: failure analysis. Device history evaluation. Results: failure analysis - returned instrument/product condition. There was a mouth prop in used condition, not showing any unusual markings. The returned mouth prop showing wear, and bent rubber and broken with metal protruding out. Upon visually inspecting the mouth prop, it is noticed that the rubber is bit up. The condition of the instrument reveals misuse. Device history evaluation: nonconforming product report/nonconforming material report history. There is no applicable nonconforming product report/ nonconforming material report history. Variance authorization/deviation history: none. Engineering change order/manufacturing change order history. There is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the complaint report has been confirmed, the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00030 |
| MDR Report Key | 4849876 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-06-15 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-06-25 |
| Date Added to Maude | 2015-06-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOUTH PROP - BLACK, MED |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | EIF |
| Date Received | 2015-06-15 |
| Returned To Mfg | 2015-06-02 |
| Catalog Number | 700601-1509-001 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2015-06-15 |