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

Model Number	411805
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 9 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 the starter hole was off-centered.It was unknown whether the end user used the product.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
No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.In addition, a complaint search for lot 0k04372 and malfunction code skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only) was carried out and as a result, no additional complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure work instructions (wi), it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed.Lot 0k04372 was manufactured on 11/05/2020, ats#2, with a total of (b)(4) units.Complaint investigator performed a batch record review on 04/30/2021, description natura stoma flatmold 33/57mm1x10pkgb/nl to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct.System application product (sap) material 1222851 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.No additional action is required, and this complaint 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: 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: 11559705
• Report Number: 9618003-2021-00451
• Device Sequence Number: 16882831
• Product Code: EXE
• UDI-Device Identifier: 00768455187058
• UDI-Public: 00768455187058
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 10/04/2025
• Device Model Number: 411805
• Device Lot Number: 0K04372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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