MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; POUCH, COLOSTOMY

Model Number 404016

Device Problem Sharp Edges (4013)

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

Event Type  malfunction  

Manufacturer Narrative

Device 5 of 27.(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 reported that 27 pouches from 3 boxes with the same lot were "bad".She stated that it was "horrible" with "no quality control whatsoever".The pouch film around flange was not cut completely out.It was 1/2 in and 1/2 out.The edges of the pouches were jagged at drainage site.She had to take scissors and cut away the excess jagged pieces.The other edges around the top of the pouches had been ragged and / or had been put together haphazardly leaving a ¿melted¿ type of mark (photos sent months ago).She stated that "somebody should at least care about stuff like this".The end user reported that this was robbery and shameful and she was reporting it to her local ostomy support group to see if others were experiencing similar things.She could not have a sense of security with this type of inferior product.It was unknown if product was used.No photo is available at this time.

Event Description

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

Manufacturer Narrative

Additional information (h10) - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary: correction (g1) - contact office address: (b)(6).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 1b00108 was manufactured on 02/10/2021 in the 11d manufacturing line, with a total of (b)(4) mkus.On 11/25/2021, complaint investigator 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 1169509 and manufacturing order (b)(4).No issues related to the defect were found in the documentation.On 11/25/2021 a complaint search for lot 1b00108 and malfunction was carried out and as a result, no additional complaints were found; therefore, no potential trend was observed.As per complaint manufacturing investigation, 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.The investigation associated with related event was approved and complete.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: L3O0200 - NATURA
• 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
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 12195726
• MDR Text Key: 262498039
• Report Number: 9618003-2021-01530
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 404016
• Device Lot Number: 1B00108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2021
• 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
• Patient Sex: Female