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

Model Number 420696

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Tissue Breakdown (2681)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 285822594
• Report Number: 9618003-2021-02761
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455189557
• UDI-Public: 00768455189557
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 420696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66
• Patient Sex: Female