MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number 404592

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Ulcer (2274); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This emdr is being submitted since open areas were reported for which steroid injections were given and based on photo reviewed, upon clinical review it appeared that pyoderma was present.However, it was unclear that product caused the condition.Also, it did not appear that any leakage was present from the device.Name of other company's dressing applied - telfa.Name of steroid injection - kenalog.Name of medication prescribed - humira (generic name - adalimumab).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).Manufacturing site: (b)(4).

Event Description

The end user stated that an issue was started one year ago when he developed open areas to the peristomal skin from four-six o'clock shown in photograph received from him.The issue was reported for one out of ten wafers of a market unit box.He had this issue since he changed to another product and the open areas continued, but they started when he was wearing the current reported product, therefore, it was unknown if the product was the cause.The end user did not report any sharp or rough edges.Wear time reported was two days.He had seen several doctors and no diagnosis had been given.He had a computed tomography (ct) scan and magnetic resonance imaging (mri) which showed an unrelated rectal fistula indicating he had an active crohn's disease.He saw a dermatologist for biopsies to rule out cutaneous crohns and pyoderma but the results were inconclusive.He had also seen his surgeon and gastroenterologist.He had received steroid injections into the open areas, been on oral steroids, used steroid spray on the ulcers.The purulent drainage had lessened.He applied other company¿s dressing over the open areas.His doctor had prescribed medication and the issue is less now that he is back on the medication.

• Brand Name: L3O0200 - NATURA
• Type of Device: PROTECTOR, OSTOMY
• 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: 15174172
• MDR Text Key: 297324213
• Report Number: 9618003-2022-04571
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 00768455126668
• UDI-Public: 00768455126668
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• 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