MalfunctionEZL

3 WAY FOLEY CATHETER 22FR

Received Jan 12, 2024 · Event occurred Nov 7, 2023

Report MW5150203 · MDR key 18517848

Device

Generic name

Catheter, Retention Type, Balloon

Manufacturer

Coloplast Manufacturing France, Sas

Patient

73 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

POST-OP AQUABLATION PTS - CATHETER BALLOON APPEARED TO DEFLATE AND FELL OUT WHEN STAFF MANUALLY IRRIGATING CATHETER/BLADDER- REPORTED THAT THIS HAD HAPPENED 2-3 TIMES PREVIOUSLY.