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

Model Number	413161
Medical Device Problem Codes	Complete Blockage (1094); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
The end user stated that she tried one wafer and it swelled up and covered her stoma.She believed that this caused an obstruction, preventing effluent from entering the pouch for over one hour.She also reported that once the wafer was removed, she had output.It was advised that if the stoma does not protrude well, it could cover the stoma.Reportedly, convexity was suggested but she refused.She also stated that she tried 413161 before and this did not happen but that the wafers she received and were labeled 413161 looked different.It was also reported that the patient¿s effluent varies from watery to loose consistency.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
Batch record review results: lot 1c05116 was manufactured on 04/09/2021 in the minilink #3 manufacturing line, with a total of (b)(4) mkus.On 12/oct/2021, a batch record review was performed to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom.The testing results were found satisfactory.Therefore, no discrepancy related to this issue were found within the documentation.On 12/oct/2021, a complaint search for lot 1c05116 and malfunction code ost-pmc01.12 skin barrier migrates and obstructs stoma was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed and this case is considered an isolated incident.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
• MDR Report Key: 12525074
• Report Number: 9618003-2021-02292
• Device Sequence Number: 4102760
• Product Code: EXE
• UDI-Device Identifier: 00768455130931
• UDI-Public: 00768455130931
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/01/2021

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: No Information
• Device Expiration Date: 03/08/2026
• Device Model Number: 413161
• Device Lot Number: 1C05116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1