inforMED
MalfunctionGDG

ADSON SUTURE 4-3/4 W/PLAT

Received Dec 30, 2014 · Event occurred Dec 10, 2014

Report 2523190-2014-00075 · MDR key 4383936

Device

Generic name

M5 - General Surgery

Catalog number

6-123

Lot number

UNK

Product problems

  • Break

Patient

59 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

CUSTOMER INITIALLY REPORTS A BROKEN TIP. ON (B)(6) 2014 CUSTOMER REPORTS THAT THE DOCTOR WAS EXCISING A LIPOMA WHEN THE TIP BROKE AS HE GRASPED TISSUE. TIP WAS EASILY REMOVED, XRAY NOT NECESSARY. NO HARM DONE.

Additional Manufacturer Narrative

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATEION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.