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

Model Number 416749

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device 7 of 10.(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 10 pieces in 1 package had an off centered starter hole.The products were not used.No photo is available at this time.

Manufacturer Narrative

Investigation summary: no samples or photos were received for analysis and investigation; 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 0f03862.Lot 0f03862 was manufactured on 6/27/2020 in the convex one-piece line, with a total of 368 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 bill of materials (bom), system application product (sap) material (b)(4), international commodity code (icc) code 416749 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 0f03862 and malfunction 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 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, as per procedure.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
• 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: 10934285
• MDR Text Key: 219154311
• Report Number: 9618003-2020-15466
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455188581
• UDI-Public: 00768455188581
• Combination Product (y/n): N
• 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
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 416749
• Device Lot Number: 0F03862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1