MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-05 for OMNI-FLEX SUPPORT ARM 11050 manufactured by Integra York, Pa Inc..
[64010988]
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
[64010989]
Omni retractor and the flex arm were not locking to the individual arms. Doctor does not think the device is safe to use. On 12/30/2016 no further information available.
Patient Sequence No: 1, Text Type: D, B5
[69131669]
On 2/13/17 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - product was not released for inspection. Device history evaluation - a dhr review cannot be performed at this time as the lot number was not provided nor was the product sent in for inspection. This review will take place once either or has been provided. Conclusion: the device was not released for evaluation therefore the root cause to the end users experience could not be determined. This complaint will be reopened should we receive product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00018 |
| MDR Report Key | 6227312 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-05 |
| Date of Report | 2016-12-15 |
| Date Mfgr Received | 2017-02-13 |
| Date Added to Maude | 2017-01-05 |
| 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 LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI-FLEX SUPPORT ARM |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-01-05 |
| Catalog Number | 11050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-01-05 |