MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-02-20 for MOUTH PROP - BLACK, LRG SCHEIN 1000298 manufactured by Integra York Pa Inc.
[20018166]
Dealer reports several patients experienced an allergic reaction during or after contact with the mouthprop and one pt even developed a more severe eczema after leaving the practice, which was reported by the dentist to (b)(6). No further info at this time.
Patient Sequence No: 1, Text Type: D, B5
[20280516]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
[26855646]
On 8/28/2015 integra investigation completed. Method: failure analysis, device history evaluation. Results: returned two mouth props in used condition, not showing any unusual markings. 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: there is no applicable corrective action preventive action history health hazard evaluation history: none. Conclusion: the lab analysis determined the composition material is not a sensitizer. The complaint report cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00009 |
| MDR Report Key | 4541887 |
| Report Source | 08,DISTRIBUTOR |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-26 |
| Date Mfgr Received | 2015-08-28 |
| Date Added to Maude | 2015-03-20 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 8006542873 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOUTH PROP - BLACK, LRG SCHEIN |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | JXL |
| Date Received | 2015-02-20 |
| Returned To Mfg | 2015-03-30 |
| Catalog Number | 1000298 |
| 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 | 2015-02-20 |