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

Model Number	413160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Itching Sensation (1943); Peeling (1999); Tissue Breakdown (2681); Skin Infection (4544)
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user stated that peristomal skin under the entire tape collar was red, with a "sunburn" appearance and it was itchy, weepy, and peeling.The issue started three months ago under the tape collar under the pouch and was under the entire tape collar now.She had been using this product for many years without issue.She saw a dermatologist who did a skin culture swab to the area around the wafer but not to the area under the tape collar.The results showed bacteria for which she received treatment with a prescription oral anti-bacterial medication.The dermatologist referred her to a nurse.The end user then saw a wound nurse who prescribed triamcinolone spray every three days with appliance change.That had provided some improvement and the area was no longer weepy.She has also trialed an anti-fungal powder that she had on hand for unrelated issue.The triamcinolone spray worked better.The end user's stoma measured twenty-eight mm.She cleansed with an anti-bacterial soap and did not use protective barrier wipes or adhesive remover wipes.No photo is available at this time and she continued using the product.

• Brand Name: L3O0200 - NATURA
• Common Device Name: 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: 13533668
• Report Number: 9618003-2022-00146
• Device Sequence Number: 17161936
• Product Code: EXE
• UDI-Device Identifier: 00768455130924
• UDI-Public: 00768455130924
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 413160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70
• Patient Sex: Female