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

Model Number	125271
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported that there was one wafer in the market unit that had an off centered pre-cut opening.He was concerned that he would develop a leak if he used the wafer, so he chose not to use it.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
D4: udi # added batch record review: the batch record review supports that there were no discrepancies related to the issue reported.This batch was manufactured following the applicable procedures, all machine and testing parameters were in accordance with the applicable procedures and specifications, the testing results were found satisfactory and no nonconformance related to the malfunction code in analysis was noted.The line clearance was executed per (b)(4) ¿procedimiento de despeje de línea y chequeo de seguridad¿, the results were documented, and no issues were identified during the manufacturing process.The materials comply with the correct parameters, pi, ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Executive summary of the nc: during the event summary and impact evaluation of this nonconformance report (ncr), with the support of the triage team expertise and the analysis of the applicable pfmeas, the most probable causes of the problem identified.A opportunity in the process was identified, since there is no functional or dimensional test implemented to inspect the concentricity of the disc in the mlk's.A visual test is currently being performed, but this defect may be visually imperceptible to the operator.A capa plan will be open to cover the preventive / corrective action resulted from this ncr.Furthermore, an ncr search conducted shows that no adverse trend was identified from january 2019 to november 2020 for this failure mode.For this reason, no additional investigation is needed.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092; manufacturing site: 9618003.

• Brand Name: L3O0200
• Common Device Name: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 10933970
• Report Number: 9618003-2020-15436
• Device Sequence Number: 871325
• Product Code: EXE
• UDI-Device Identifier: 00768455125180
• UDI-Public: 00768455125180
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/13/2020

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 Expiration Date: 03/02/2025
• Device Model Number: 125271
• Device Lot Number: 0C04682
• 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: 11/13/2020
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2020
• 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