MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-09 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[16945131]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
[16991242]
On an unknown date, components of the a1040 (budde halo retractor) had issues found at incoming inspection of goods by the distributor. There was no patient contact or patient injury. (adjustment wrench assembly) (b)(4); the wire was disconnected (continutrac halo ring) (b)(4); the parts of both side surfaces were not attached. (9 inch retractor arm assembly) (b)(4); the tip part was not completely fixed; it may move.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2014-00079 |
| MDR Report Key | 3928503 |
| Report Source | 01,08 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-05-15 |
| Date Mfgr Received | 2014-05-15 |
| Date Added to Maude | 2014-07-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| 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 | BUDDE HALO RETRACTOR |
| Generic Name | NA |
| Product Code | GZT |
| Date Received | 2014-06-09 |
| Catalog Number | A1040 |
| Lot Number | 139 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2014-06-09 |