MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE POUCH, COLOSTOMY

Model Number 022771

Device Problem Sharp Edges (4013)

Patient Problems Laceration(s) (1946); Pain (1994); Discomfort (2330); Tissue Breakdown (2681)

Event Type  malfunction  

Manufacturer Narrative

Contact office address: (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).

Event Description

The end user applied 1 out of box of 10 wafers and it caused pain to the stoma. She further stated that "when cutting wafer, some sharp edges were left, which cut a bit into her stoma" (possibly resulting in pain/discomfort). She was not cutting beyond the cutting guide. The sharp edges were after the wafer was cut. Reportedly, the pouch was not the correct size for her stoma. The end user continued to use the product. No photo available is available at this time.

• Brand Name: L3O0100 - ACTIVE LIFE
• 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: 12622471
• MDR Text Key: 281432459
• Report Number: 9618003-2021-02570
• Device Sequence Number: 1
• Product Code: EZQ
• 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

• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 022771
• Device Lot Number: 9F02271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown