MAUDE Adverse Event Report: CONVATEC INC L3O0675 - ESTEEM+

Model Number 421621

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Contact Dermatitis (4546)

Event Type  Injury  

Manufacturer Narrative

Common device name: pouch, colostomy.Contact office address: dr.(b)(6).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: (b)(4).

Event Description

The end user tried a sample product, which aggravated the pre-existing symptoms of burning, itching and the red skin condition started happening "all over my body".After a few hours, she went to the emergency room.She was diagnosed with contact dermatitis, was started on prednisone and was referred to an allergy doctor.The allergist prescribed an antihistamine (brand unknown) and topical cream to be used on the peristomal skin (brand unknown).The consumer left her pouch off for several days so that the cream could be applied.Thereafter, she was wore a non-company product and her skin was slowly improving.No photo is available at this time.

• Brand Name: L3O0675 - ESTEEM+
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7900 triad center drive; suite 400; greensboro, NC ; 3365424681
• MDR Report Key: 11804770
• MDR Text Key: 264774590
• Report Number: 1049092-2021-00069
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 421621
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• 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: 57