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

Model Number	413183
Medical Device Problem Codes	Fluid/Blood Leak (1250); Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 2 of 10.(b)(6).(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
It was reported that customer complained that the starter hole was off-centered resulting in leakage within 1 day of wear time.No harm was reported to the patient.Photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
The emdr with manufacturer report number (mdr 9618003-2021-02718), submitted on 11/24/2021 was submitted in error as this case was determined to be not reportable.Please retract the report.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.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 12867693
• Report Number: 9618003-2021-02718
• Device Sequence Number: 17648449
• Product Code: EXE
• UDI-Device Identifier: 00768455124534
• UDI-Public: 00768455124534
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: Other
• Device Expiration Date: 11/06/2025
• Device Model Number: 413183
• Device Lot Number: 0L00808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2020
• 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: Unknown