MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+; POUCH, COLOSTOMY

Model Number 416409

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Type  Injury  

Manufacturer Narrative

This emdr is being submitted since it was unclear that how long stool was sitting on the skin and how long the leakage was present.Based on the available information, this event is deemed to be a serious injury.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.Specialist's name: (b)(6).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

This emdr is being submitted for an unknown number of pouches.The end user spoke to the specialist on (b)(6) 2022 that most of the pouches were affected.He also reported that as a result of the pouches leaking, stool was able to get on his skin under the wafer and he was admitted to the hospital for cellulitis and treated with amoxicillin.The consumer changed the pouch three to four times a day.He also preferred closed ended pouches.He denied that an ill-fitting wafer caused the leakage.He also stated extensive soilage of clothing and bed linens.He stated that now he had started a new box of pouches, he did not experience any further problems and that his skin had healed.No photo is available at this time.

• Brand Name: L3O0215 - 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: 14771183
• MDR Text Key: 294531311
• Report Number: 9618003-2022-00610
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2022
• 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: 53
• Patient Sex: Male