FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL NECK SLEEVE
MDR report key: 3980226
·
Received August 5, 2014
Report
- Report Number
- 3010536692-2014-01024
- Event Type
- Injury
- Date Received
- August 5, 2014
- Date of Event
- July 9, 2014
- Report Date
- July 10, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-01023, 01025, 01026.
Description of Event or Problem · 1
ALLEGEDLY PT COMPLAINED OF HIP PAIN - THOUGHT TO BE INFECTED - REVISED. DR. (B)(6) WANTS TO CHECK FOR ALVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458055 | CONSERVE(R) TOTAL NECK SLEEVE | HIP COMPONENT | LZO | MICROPORT ORTHOPEDICS INC. | 0701178719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |