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

Model Number	175778
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that sharp plastic piece was poking through convex portion of pouch.She stated that she saw the defect prior and did not use the product.No photo is available at this time.
Additional Manufacturer Narrative
Correction - contact office address: (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).
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.(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: the lot 1c04480 was manufactured on 04/10/2021, convex 1 pc manufacturing line, with a total of (b)(4) market units.Complaint investigator id 6055 performed a batch record review on 11/26/2021 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.Sap material 1000618 and manufacturing order 1569244.The batch record review supports that there were no discrepancies related to the issue reported.On 11/26/2021 a complaint search for lot 1c04480 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 procedure, it is not required to open a nonconformance report (ncr) for 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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: L3O0100 - ACTIVE LIFE
• Common Device Name: 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: 12874045
• Report Number: 9618003-2021-02688
• Device Sequence Number: 19960640
• Product Code: EZQ
• UDI-Device Identifier: 00768455181247
• UDI-Public: 00768455181247
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Expiration Date: 04/09/2026
• Device Model Number: 175778
• Device Lot Number: 1C04480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown