MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-18 for UNIVER TOFFLEMIRE TYPE RE 72-34 manufactured by Integra York, Pa Inc..
[57722444]
Integra has completed their internal investigation on october 12, 2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: evaluation of returned device; there were ten tofflemire retainers returned with no unusual markings and complaint stating that the doctor cut himself. Upon further investigation it is found that most do have sharp edges on them. Dhr review; there is no applicable nonconforming product report / nonconforming material report history complaints history; complaint metrics tracked, trended, and reviewed monthly with management. Conclusion: the complaint report is confirmed; the root cause has been determined to be a workmanship or material deficiency. Appropriate action has been implemented to rectify this manufacturing deficiency.
Patient Sequence No: 1, Text Type: N, H10
[57722445]
Customer initially reports device defective cuts doctors hand. On 9/30/2016 doctor reports she was applying a band to a lower r back molar when she was cut on sharp threads of the device. No special treatment necessary, no infection. No harm to patient
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00168 |
| MDR Report Key | 6036495 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-26 |
| Date Mfgr Received | 2016-09-26 |
| Date Added to Maude | 2016-10-18 |
| 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 | 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 | 2016-10-18 |
| Returned To Mfg | 2016-10-12 |
| Catalog Number | 72-34 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-10-18 |