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

Model Number	413178
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); 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
This emdr is being submitted since he had excessive bleeding while using company¿s device from constant sore which was not caused by company's device.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 or Problem Description
This emdr is being submitted for an unknown number of wafers from an unknown number of boxes.The end user reported bleeding from the constant sore started in (b)(6) 2021 and then again in (b)(6) 2021 when he received cauterization to the affected area.In (b)(6) 2022, the sore started to bleed again and was cauterized by his doctor two weeks ago.Consumer had three episodes of bleeding in one week since the cauterization.The first episode of bleeding filled his pouch one and half times, the second episode of bleeding filled his pouch, and the third episode of bleeding filled his pouch halfway.He stated he had gone to the emergency room three times this year, two of them in april.He had intermittent bleeding that was usually resolved by applying pressure for several minutes except on the occasions mentioned above.No leakage was noted during these episodes.He stated that he changed his wafer when the bleeding occurred.It was further reported that the constant sore was not caused by company¿s device.He did not use adhesive remover to remove skin barrier.He could not confirm his stoma size.Consumer stated there was no hernia present and his abdomen was between soft and firm.No photo is available at this time.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
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: 1049092, manufacturing site: 9618003.

• 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: 14872455
• Report Number: 9618003-2022-00603
• Device Sequence Number: 5060956
• Product Code: EXE
• UDI-Device Identifier: 00768455124480
• UDI-Public: 00768455124480
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 06/02/2022

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: 413178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male