MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+; POUCH, COLOSTOMY

Model Number 416749

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 2.(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.(b)(4).

Event Description

It was reported that the starter hole was off centered.The product was not used on patient.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

Correction (g1) - contact office address: dr.(b)(6) 7815 national service road suite 600 greensboro, nc 27409 (b)(6).No samples were received for evaluation by the customer.A photo was received as additional information, however based on the visual evaluation, the defect could not be confirmed; for that reason, the malfunction reported by the customer could not be confirmed.On 10/may/2021, a batch record review was performed for lot 0j00872.Lot 0j00872 was manufactured on 9/8/2020 in the convex one piece line, with a total of (b)(4) mku.Based on the review carried out, all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, sap material (b)(4), icc code (b)(4) and manufacturing order (b)(4).The process was run according to process instruction pi21-076, documented in the mr21-076.Batch record review carried out supports that no issues related to the problem were identified.In addition, a complaint search for lot 0j00872 and malfunction code ost-pmc01.08 skin barrier starter hole is defective (e.G.Misalignment or off center), leakage may occur (pre-cut only) was carried out and as a result, no additional complaints were found; therefore, no trend for this lot is observed.As per complaint manufacturing investigation procedure (b)(4), version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed (either by photos or samples provided by the customers or results of the batch record review) and no potential trend is identified.Therefore, for all explained above, 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: L3O0675 - ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 11327146
• MDR Text Key: 231975141
• Report Number: 9618003-2021-00201
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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
• Device Operator: Other
• Device Model Number: 416749
• Device Lot Number: 0J00872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1