MAUDE Adverse Event Report: Coloplast A/S - Mordrup Site SenSura Mio Click Ostomy Pouch; Collector, Ostomy

Model Number	11402
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
My mother, (b)(6), wears a disposable colostomy pouch from coloplast (item number 11402).The pouches routinely arrive folded and creased, as they are mishandled in the packaging by the company (i.E., shoved into the box without regard for the product's integrity).The result is pouches that are compromised in function due to careless handling by the company.I have reported the issue to coloplast numerous times to no avail.I am hoping the fda can intervene with the manufacturer and enforce quality standards to resolve this ongoing problem.

• Brand Name: SenSura Mio Click Ostomy Pouch
• Common Device Name: Collector, Ostomy
• Manufacturer (Section D): Coloplast A/S - Mordrup Site
• MDR Report Key: 50778736
• Report Number: MW6002336
• Device Sequence Number: 15845481
• Product Code: EXB
• UDI-Device Identifier: 05708932926607
• UDI-Public: (01)05708932926607
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11402
• Device Lot Number: (10)10877236
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 90 LB
• Patient Race: White