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

Model Number 022771

Device Problem Device Handling Problem (3265)

Patient Problems Erythema (1840); Itching Sensation (1943); Fungal Infection (2419); Tissue Breakdown (2681); Blister (4537)

Event Type  Injury  

Event Description

The end user provided very limited information and reported that this was an ongoing issue for years and could not provide date of onset.She also stated that she was a multi-product user as she had a known diagnosed allergy to adhesives and did not get good results with non-adhesive system.She now discontinued the use of company's product and alternated with other manufacturers which seemed to keep her skin in check.However, when she did not rotate, her skin appeared red with blisters, weeping, itching and a fungal overgrowth for which she required antibiotics and anti-fungal.She also stated that this had occurred under both the mass and tape collar on the product.She declined to provide additional information such as the name of the medications, the time when she needed a medication for use of the convatec product and declined to provide the photos also.

• 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: 13868597
• MDR Text Key: 287827836
• Report Number: 9618003-2022-00260
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2022
• 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: 48
• Patient Sex: Female