MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for UNIVER TOFFLEMIRE TYPE RE 72-34 manufactured by Integra York, Pa Inc..
[54401317]
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
[54401318]
Customer initially reports doctor was cut, item doesn't work well. On (b)(6) 2016 doctor reports she was cut through her glove by matrix band when she tried to apply it with the device. Needed to apply a lot of pressure. No harm done.
Patient Sequence No: 1, Text Type: D, B5
[55353164]
On 9/1/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis: there were (b)(4) tofflemire retainers returned with no unusual markings. Upon further investigation it is found that some do have sharp edges on them. The complaint report is confirmed. 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: (b)(4) issued (b)(6) 2010 functional issues during use health hazard evaluation history: none. Conclusion: the root cause has been determined to be a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00129 |
| MDR Report Key | 5919576 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-06-24 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-08-31 |
| 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 | 6099362393 |
| 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 | UNIVER TOFFLEMIRE TYPE RE |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | JEP |
| Date Received | 2016-08-31 |
| Returned To Mfg | 2016-08-17 |
| Catalog Number | 72-34 |
| Lot Number | UNKNOWN |
| 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 | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-31 |