MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC; Pouch, colostomy

Model Number 404592

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-10414/ device 2 of 11.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 Description

The end user reported that wafers from two market units had an off-centered starter hole.Reportedly, 5 from box 1 and 6 from box 2 were affected.The products were not used.No photo is available at this time.

Event Description

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

Manufacturer Narrative

Batch record review: lot 8c00506 was manufactured on 03/09/2018, line convex 2 pc 2, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 11/17/2020, 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, under international commodity code (icc) 404592 system application product (sap) material 1156500 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.There are no photographs associated with this case and no unused return sample was expected.Investigation conclusion: 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 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.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.

• Type of Device: Pouch, colostomy
• 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: 9353158
• MDR Text Key: 174852628
• Report Number: 9618003-2019-10414
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455126668
• UDI-Public: 00768455126668
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2023
• Device Model Number: 404592
• Device Lot Number: 8C00506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/23/2023
• 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