MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; POUCH, COLOSTOMY

Model Number	420696
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction - contact office address: (b)(4).Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number (b)(4).
Event or Problem Description
End user stated that tap of one pouch was hard and dug into her skin.No open areas were reported and there was no leakage involved.Wear time was not provided.She discontinued the product and was wearing another product and the issue was resolved.No photo is available at this time.

• Brand Name: L3O0200 - NATURA
• Common Device Name: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 12982220
• Report Number: 9618003-2021-02761
• Device Sequence Number: 20269697
• Product Code: EZQ
• UDI-Device Identifier: 00768455189557
• UDI-Public: 00768455189557
• Combination Product (Y/N): N
• Initial Reporter State: IA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 420696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66
• Patient Sex: Female