MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; BAG, URINARY, ILEOSTOMY

Model Number 175794

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.No sample, video or photo was received for evaluation; for that reason, the malfunction reported by the customer could not be confirmed.Batch record review results: lot 0g01979 was manufactured on 07/19/2020 in the (b)(4) manufacturing line, with a total of (b)(4) mkus.On 29/sep/2021, compliance engineer (b)(4) performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, under sap material (b)(4) and manufacturing order (b)(4).The testing results were found satisfactory.Therefore, no discrepancy related to this issue were found within the documentation.On 29/sep/2021, a complaint search was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed and this case is considered an isolated incident.It is not required to open a nonconformance report (ncr) for complaints which were not confirmed and no potential trend is identified (therefore, considered an isolated incident).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.(b)(4).

Event Description

The end user reported that wafer with starter hole was off centered.The product was not used and no photo is available at this time.

• Brand Name: L3O0100 - ACTIVE LIFE
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• MDR Report Key: 12597054
• MDR Text Key: 283413712
• Report Number: 9618003-2021-02471
• Device Sequence Number: 1
• Product Code: EXH
• UDI-Device Identifier: 00768455181360
• UDI-Public: 00768455181360
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 09/15/2021

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: No Information
• Device Model Number: 175794
• Device Lot Number: 0G01979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1