MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-12-16 for 9 INCH RETRACTOR ARM ASSEMBLY 438A1011 manufactured by Integra Lifesciences Corporation Oh/usa.
[5222650]
The tightening mechanism was damaged. The defect was detected during surgery. There was no patient injury or surgery delay reported. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[12672480]
It is unk if the device involved in the reported incident is expected to be returned for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2014-00238 |
| MDR Report Key | 4350878 |
| Report Source | 01 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-11-19 |
| Date Mfgr Received | 2014-11-19 |
| Date Added to Maude | 2015-01-05 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9 INCH RETRACTOR ARM ASSEMBLY |
| Generic Name | RETRACTOR SYSTEM COMPONENTS |
| Product Code | GZT |
| Date Received | 2014-12-16 |
| Catalog Number | 438A1011 |
| 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 LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-16 |