FDA Adverse Event
Malfunction
Summary report: N
BUDDE HALO RETRACTOR
MDR report key: 3994699
·
Received June 11, 2014
Report
- Report Number
- 3004608878-2014-00090
- Event Type
- Malfunction
- Date Received
- June 11, 2014
- Report Date
- May 15, 2014
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION OH/USA
- Product Code
- GZT
- PMA / PMN Number
- K830332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344702 | BUDDE HALO RETRACTOR | RETRACTOR SYSTEMS | GZT | INTEGRA LIFESCIENCES CORPORATION OH/USA | 139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |