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

Model Number	125263
Medical Device Problem Codes	Material Disintegration (1177); Material Erosion (1214); Device Emits Odor (1425); Positioning Problem (3009)
Health Effect - Clinical Codes	Diarrhea (1811); Pain (1994); Skin Discoloration (2074)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that wear time was less than one day with three wafers in box.The usual wear time of wafer was ten days.She had used the same wafer for thirty years with no issue.On (b)(6) 2023, she noted a strong chemical odor after hours after application of new wafer.The end user also stated that the mass was disintegrated and melted off her body.She reported no change in stoma or routine and stoma was smaller than 1 inch.She also reported two white patches on her stoma.There was no bleeding or laceration observed.The end user reported that she saw an ostomy nurse two weeks ago then who said to watch them for now and one of the spots had become larger since that visit.She also stated that she saved the last wafer in her freezer to show the disintegration.She also had two unused wafers from the box.She also stated that she had plans to send them to a lab to have tested.It was her opinion she was exposed to a chemical that was causing the white spots and now she was having severe stomach pain and diarrhea.She had not slept in three days then.She was trying to see her doctor that day.She had thrown the box away and does not have lot number.Clinical input was provided that stated based on picture, it does appear to be exposed plastic film in one of the wafers.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
A2: age at the time of event - 56 years.Based on the available information, this event is deemed to be a reportable malfunction.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: 1049092.Manufacturing site: 9618003.

• Brand Name: 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: 17962931
• Report Number: 9618003-2023-07949
• Device Sequence Number: 6799615
• Product Code: EXE
• UDI-Device Identifier: 00768455125425
• UDI-Public: 00768455125425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 125263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/19/2023
• 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: Female