MAUDE Adverse Event Report: CYMED CYMED MICROSKIN ONE PIECE 9" UROSTOMY POUCHES WITH PLAIN MICROSKIN BARRIER; BAG, URINARY, ILEOSTOMY

Model Number 86322

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  Injury  

Event Description

Urostomy pouching system leaking seriously on every pouching bag.I must change pouching system every time it is leaking.Normally we need to change pouching system every other days.10 bags per month.Now it cost more than 35 bags per month.According to medical requirements frequently changing will cause infection.I have transplant kidney.So it will cause infection of my transplant kidney.Need fda investigation it's processing to make so many malfunctions urostomy pouching systems.It will cost patients' life.

• Brand Name: CYMED MICROSKIN ONE PIECE 9" UROSTOMY POUCHES WITH PLAIN MICROSKIN BARRIER
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CYMED; 1451 sarasota center blvd.; sarasota FL 34240
• MDR Report Key: 18103023
• MDR Text Key: 327990144
• Report Number: MW5147996
• Device Sequence Number: 1
• Product Code: EXH
• UDI-Device Identifier: 00383950863209
• UDI-Public: (01)00383950863209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2023
• Device Model Number: 86322
• Device Lot Number: PC230048
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening