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

Model Number	125265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction - contact office address: (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: reporting site: (b)(6).Manufacturing site: (b)(4).
Event or Problem Description
The end user reported that approximately 4-5 months ago, he unknowingly cut his wafer/skin barrier opening too small for his stoma per his local ostomy nurse.His stoma size had changed from 25mm to 45mm.As a result, he developed bleeding with petechiae from 3-6 o' clock on the stoma mucosa.Reportedly, he did not report a cut or other injury on the stoma.Also, local ostomy nurse was using silver nitrate to cauterize the bleeding for several weeks, and even after sizing the wafer opening correctly, the bleeding persisted.He visited ostomy nurse 1 month ago.He also reported that occasional bleeding throughout the day was visible in pouch, not associated with any activity.The bleeding sometimes lasted for an hour and stopped with pressure.The end user also stated that he does not wear an ostomy wrap or binder and does not have his waist band or seat belt over the stoma at any time.He stated that he also had a grapefruit-sized bulge just below the stoma.His usual wear time was 2-3 days.He reported that he did not preferred use of adhesive remover, but he usually removed his wafer, very carefully in the shower with ivory soap and kept the shower head at a gentle setting.He also used allkare skin protectant and an eakin cohesive slim.He had also been applying liquid-band-aid to the affected area on the stoma mucosa.Consumer was strongly advised to follow-up with a surgeon/doctor.Reportedly, the end user continued to use the product.No photo is available at this time.

• 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
• MDR Report Key: 12663110
• Report Number: 9618003-2021-02605
• Device Sequence Number: 1231273
• Product Code: EXE
• UDI-Device Identifier: 00768455125449
• UDI-Public: 00768455125449
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/28/2021

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: No Information
• Device Model Number: 125265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61