FDA Adverse Event
Malfunction
Summary report: N
REBOUND HRD
MDR report key: 6260604
·
Received January 18, 2017
Report
- Report Number
- 3005770977-2017-00001
- Event Type
- Malfunction
- Date Received
- January 18, 2017
- Report Date
- January 18, 2017
- Manufacturer
- ARB MEDICAL, LLC
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED TO THE MANUFACTURER. METAL FATIGUE IS SUSPECTED SEPARATION CAUSE. THIS TYPE OF SEPARATION IS RARE (ESTIMATED AT 00.03% OF DEVICES IMPLANTED). THIS EVENT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT HAS NO PERMANENT INJURY OR SERIOUS DETERIORATION TO HEALTH THE DEVICE WAS REMOVED. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
EIGTHT MONTHS AFTER IMPLANTATION PATIENT RETURNED WITH RECURRING HERNIA. PATIENT WAS X-RAYED. A SEPARATION OF THE FRAME OF THE DEVICE WAS OBSERVED ON THE X-RAY. DEVICE WAS REMOVED WITH NO ADVERSE EFFECTS TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42908 | REBOUND HRD | HERNIA REPAIR DEVICE | FTL | ARB MEDICAL, LLC | RB-SLD-LSO-PP | 140045 OR 140055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |