MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-01-06 for BARNHART 1/2 CUR RSN HDL 70-5202 manufactured by Integra York, Pa Inc..
[35210861]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[35210862]
Customer initially reports device broke. On (b)(6) 2015 customer reports all three devices the curette came off the handle while in the patients mouth during teeth cleaning, no harm done. Pieces retrieved immediately in each case. #2 of 3 same complaint.
Patient Sequence No: 1, Text Type: D, B5
[36362006]
On 12/23/2015 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - there was a curette returned in used condition, not showing any unusual markings, and minimal wear. Evaluation shows that the one curette tip has fallen out of the handle. The complaint is confirmed. Device history evaluation - nonconforming product report / nonconforming material report history: none. 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 root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00151 |
| MDR Report Key | 5348747 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-01-06 |
| Date of Report | 2015-12-14 |
| Date Mfgr Received | 2015-12-23 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2016-01-06 |
| 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 | BARNHART 1/2 CUR RSN HDL |
| Generic Name | M52 - HYGIENE / PERIODONTAL |
| Product Code | EMS |
| Date Received | 2016-01-06 |
| Returned To Mfg | 2015-12-21 |
| Catalog Number | 70-5202 |
| 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 | 2016-01-06 |