MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for VALVE 1375011 ESSAR REPLACEMENT manufactured by Integra York, Pa Inc..
[57806182]
On 9/29/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned. . Unconfirmed/no return of device for evaluation. 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/corrections: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[57806183]
Having issues with integra ent essar suction irrigation. Specifically the silicone valves are leaking. Silicone breaking down extremely fast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00177 |
| MDR Report Key | 6035284 |
| Date Received | 2016-10-17 |
| Date of Report | 2016-09-02 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-10-17 |
| 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 |
| Reporter Occupation | DENTAL ASSISTANT |
| 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 | 0 |
| Brand Name | VALVE 1375011 ESSAR REPLACEMENT |
| Generic Name | PFM11 |
| Product Code | KCB |
| Date Received | 2016-10-17 |
| Catalog Number | 1375011 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-10-17 |