InjuryEHZ
REF MD5096513
Received Feb 27, 2013 · Event occurred Jan 25, 2013
Report MW5029226 · MDR key 2993991
Device
Generic name
Suction Swab Kit
Manufacturer
Medline Industries IncModel number
1--80196802104Catalog number
REF MDSO96513
Lot number
12353
Product problems
- Detachment Of Device Component
Patient
35 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ORAL CARE SPONGE BROKE OFF IN PT'S MOUTH DURING ROUTINE ORAL CARE. THE HEAD OF THE ORAL CARE SPONGE NOTED TO SNAP OFF. DEVICE FAILURE CREATED AN UNSAFE CONDITION. DATES OF USE: (B)(6) 2013 - (B)(6) 2013. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.