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

Model Number 175782

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 3.(b)(4).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 stated that the stoma opening of three wafers out of five appliances was manufactured off centered.She reported a usual wear time of three days but had leakage at the bottom of the appliance after one day which she felt was due to a defective product and not being able to perform as expected.No harm was reported and no photo is available at this time.

Event Description

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

Manufacturer Narrative

G1: correction (g1) - contact office address: (b)(4).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 0f01195 was manufactured on 06/13/2020 in the cvx1pc manufacturing line, with a total of (b)(4) mkus.On 19/aug/2021, compliance engineer id (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).No issues related to the defect were found in the documentation.On 19/aug/2021 a complaint search for lot 0f01195 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: 12280054
• MDR Text Key: 265145455
• Report Number: 9618003-2021-01650
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 175782
• Device Lot Number: 0F01195
• 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