MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-11 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[4886133]
A 438a 1011 component of the a1040 budde halo was reported to have a hole at the rail sliding portion of the unit. The event was found upon inspection; therefore, there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[12308108]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2014-00090 |
| MDR Report Key | 3994699 |
| Report Source | 01,08 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-15 |
| Date Mfgr Received | 2014-05-15 |
| Date Added to Maude | 2014-08-18 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099365560 |
| 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 | 2014-06-11 |
| Catalog Number | A1040 |
| Lot Number | 139 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-06-11 |