MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-27 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation.
[4757712]
The flex arm was faulty. It was an out of box failure, brand new set not being used on anyone. The distributor took it out for inspection before sending to the customer.
Patient Sequence No: 1, Text Type: D, B5
[12199054]
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
| Report Number | 3004608878-2014-00154 |
| MDR Report Key | 4102322 |
| Report Source | 08 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-11 |
| Date Mfgr Received | 2014-08-21 |
| Date Added to Maude | 2014-09-26 |
| 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 | 2014-08-27 |
| Catalog Number | A1040 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-27 |