MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; NOT APPLICABLE

Model Number 402203

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.Fda registration number: (b)(4).

Event Description

It was reported the starter hole is off center in 16 wafers.The product was not used and no photo was provided.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: d4: unique identifier (udi).H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (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.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/no 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.Never the less, there are seven (07) conditions that could be considered, based on objective evidences and expertise, as contributor factors for this event and, one (01) opportunities 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 action / preventive actions (capa) plan.The investigation associated with related event 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 Description

To date no additional patient or event details have been received.

• Brand Name: NATURA
• Type of Device: NOT APPLICABLE
• 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: 8141350
• MDR Text Key: 129891255
• Report Number: 9618003-2018-03941
• Device Sequence Number: 1
• Product Code: EXD
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/26/2022
• Device Model Number: 402203
• Device Lot Number: 7H06260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1