MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; BAG, URINARY, ILEOSTOMY

Model Number 650830

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

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

The end user stated that in approximately jan-2020, he contacted convatec to obtain product samples.He advised that he previously tried convatec in the past when he developed redness and pinpoint bleeding from the tape collar.The end user stated that he developed irritation, which worsened with each subsequent use of the samples provided.At some point, he developed bleeding.Reportedly, he saw his physician because he developed an infection and was given an oral antibiotic.He did not recall the name of the antibiotic and stated that he had it on record but did not wish to retrieve it at this time.The end user felt like it was related to the aggressiveness of the tape.He did use safe n simple adhesive remover to remove the appliance.He tried approximately 4 samples (history shows he was provided with 6 total pouches as a sample).No photo is available at this time.

• Brand Name: L3O0100 - ACTIVE LIFE
• Type of Device: BAG, URINARY, ILEOSTOMY
• 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 ; 7900 triad center drive; suite 400; greensboro, NC ; 3365424681
• MDR Report Key: 11449946
• MDR Text Key: 238812070
• Report Number: 9618003-2021-00299
• Device Sequence Number: 1
• Product Code: EXH
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 650830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 78