MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; POUCH, COLOSTOMY

Model Number 175779

Device Problem Malposition of Device (2616)

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

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.(b)(4).

Event Description

It was reported that the wafer had an off centered starter hole.The product was not used.No photo is available at this time.

Event Description

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

Manufacturer Narrative

(b)(6).7815 national service road suite 600 greensboro, nc 27409 336-542-4679 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 0f04603 was manufactured on 07/04/2020 in the cvx1pc manufacturing line, with a total of (b)(4) mkus.On 19/aug/2021, compliance engineer id (b)(6) 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, (b)(4).No issues related to the defect were found in the documentation.On 19/aug/2021 a complaint search for lot 0f04603 and malfunction code ost-pmc1.8 / 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 potential trend is observed.As per complaint manufacturing investigation procedure wi-0359, version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend is identified.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.

• Brand Name: L3O0100 - ACTIVE LIFE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• MDR Report Key: 12245586
• MDR Text Key: 264081696
• Report Number: 9618003-2021-01632
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 175779
• Device Lot Number: 0F04603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1