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

Model Number 175779

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Rash (2033); Urticaria (2278); Blister (4537); Skin Infection (4544)

Event Type  Injury  

Event Description

This emdr is being submitted for one wafer with unknown lot number.The consumer reported that she had been using the product for many years.She reported that for the time she was using the product she experienced a red skin condition under the mass of the wafer and sometimes under the tape collar.She described the skin reaction as bumps and hives and experienced an itching sensation which was relieved when she removed the appliance.Further, she mentioned that sometimes there was bleeding and blister formation, and it was unknown if the blisters were closed or opened.She stated while using this product she sought medical attention from a dermatologist who prescribed an unknown cream after being diagnosed with both staphylococcus and fungal/yeast infections on the skin.She used to change the product daily.She would remove the old appliance and applied a new one.She reported a skin care routine of using only water and ivory soap.She rinsed well and then dried her skin with a hair dryer.She sometimes used an unknown no sting skin barrier spray.No photo is available at this time.

Manufacturer Narrative

The event is considered as misuse since the end user was using improper device for their medical condition and/or known risk factors as the end user had long history of skin sensitivity to adhesives including band aids and tape.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.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).

• 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 (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: 16129240
• MDR Text Key: 306987097
• Report Number: 9618003-2022-05438
• 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: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2022
• 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: 63
• Patient Sex: Female