MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-12-19 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[20778395]
The hosp received the device back from repair with rusty pins at the ring. Also, there were issues with the labels on the device. There was no patient contact and no related issues reported.
Patient Sequence No: 1, Text Type: D, B5
[20963121]
To date, the device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2014-00247 |
| MDR Report Key | 4360414 |
| Report Source | 01 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-21 |
| Date Mfgr Received | 2014-11-24 |
| Date Added to Maude | 2015-01-07 |
| 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 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 | BUDDE HALO RETRACTOR |
| Generic Name | RETRACTOR SYSTEMS |
| Product Code | GZT |
| Date Received | 2014-12-19 |
| Returned To Mfg | 2014-11-24 |
| Catalog Number | A1040 |
| Lot Number | C70084_02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-12-19 |