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

Model Number 022771

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Skin Discoloration (2074); Tissue Breakdown (2681); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 02-apr-2021.This supplemental is being submitted as an initial mdr due to network issues upon submission on june 06, 2017 which failed to process.Reported to the fda on: 24-oct-2017.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

End user reported red skin under tape collar to the right side of the wafer which started approximately a couple months ago.Prior to this end user developed an unrelated staphylococcus infection to legs which moved to abdomen and underneath tape collar.She was prescribed bactrim for the staphylococcus infection and was taking prescription cephalexin capsule for the red skin under the tape collar.She reported there was some lessening to the redness under the tape collar.The doctor was uncertain if the issue is related to the staphylococcus infection or to the adhesive on the tape collar.Additionally, it was reported that the end user stated that the red skin started on the right side of the wafer at the same time as the staphylococcus infection on the legs.No pictures were provided and no further details have been provided.

• Brand Name: 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 Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 6972600
• MDR Text Key: 243521404
• Report Number: 9618003-2017-00040
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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
• Date Manufacturer Received: 02/24/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female