FDA Adverse Event
Injury
Summary report: N
FASTOUCH ABSORBABLE 5MM FIXATION SYSTEM
MDR report key: 11664024
·
Received April 13, 2021
Report
- Report Number
- MW5100763
- Event Type
- Injury
- Date Received
- April 13, 2021
- Date of Event
- April 5, 2021
- Report Date
- April 12, 2021
- Manufacturer
- VIA SURGICAL LTD.
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
FASTOUCH FIXATION SYSTEM JAMMED AFTER 5 USES. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555713 | FASTOUCH ABSORBABLE 5MM FIXATION SYSTEM | STAPLE, IMPLANTABLE | GDW | VIA SURGICAL LTD. | 17124-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |