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

Model Number	413180
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 31 of 63.An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.The complaint required to create an initial 31st emdr out of 63 emdrs that was missed initially.A capa was raised and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.E1: complainant information: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Batch records review results: batch records of final products and bulking lots were reviewed to confirm if all requirements were followed.Results of the batch records review were documented in each individual section of the 6 m¿s methodology.All impacted lots were documented in the attachment of final products with bulking lots.Sample/photo analysis results: no samples were received for evaluation/one photo was received within complaints reported.Conclusion summary of the related event: based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented and defects simulation, the specific root cause could not be identified.Nevertheless, there are seven (07) conditions that could be considered, based on objective evidence and expertise, as contributor factors for this event and, one (01) opportunity for improvement were found: 1.Materials investigations: fabric rolls not rolled uniformly, no welded or over welded flanges.2.Process/methods investigation: wrong adhesive tape used for joint fabrics rolls.Opportunities for improvement, introduce quality control (qc) tooling used for quality inspection purpose in the calibration program to guarantee measurement assurance.3.Machinery / equipment/ software investigation: different movement relation vs cardan in the yamaha arm pads.If the cognex cameras of the vision system is not clean.In the vision system, the model in the system is not centralized.When the yamaha is not adjusted if the web index is moved, due to the positioning of the vision system.No issues were identified for manpower, measurement, and environment investigations actions will be taken for each factor and are going to be summarized on corrective and preventive actions (capa) plan.The investigation has been approved and is complete.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.
Event or Problem Description
It was reported the ring of pouch is not located in the middle of 63 wafers.Per the photos received, the starter hole is off center.

• 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: 18391455
• Report Number: 9618003-2023-15375
• Device Sequence Number: 2932481
• Product Code: EXE
• UDI-Device Identifier: 00768455124503
• UDI-Public: 00768455124503
• 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
• Report Date (Section B): 10/04/2018

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: 01/02/2023
• Device Model Number: 413180
• Device Lot Number: 8A06572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2018
• 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