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