MAUDE Adverse Event Report: CONVATEC INC ESTEEM+; POUCH, COLOSTOMY

Model Number 421617

Device Problem Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

Common device name: pouch, colostomy.Complainant state/province: (b)(6), complainant country: (b)(6), name of dealer: (b)(6) health.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.Fda registration number reporting site: (b)(4), third party manufacturing site (for life): (b)(4).

Event Description

It was reported that starter hole of ten wafers was off centered.The product was not used.No photo is available at this time.

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.H10: investigation summary: c22 and d17 were selected under imdrf investigation findings and imdrf cause conclusions respectively since there is no code to describe the term "allowed deviation/tolerances for cutting guides".A batch record review indicates no discrepancies.A slightly offset hole can have the following cause: the cutting guides are not 100% evenly positioned on the carrier , according to raw material is -+ 1 mm deviation is allowed & in our technical drawings are also cutting specifications of the wafer+- 1 mm allowed, if both the position of the cutting guide on the carrier and cutting process on the machine move within allowed tolerances by +-1 mm, this could result in a total of +-2 mm.Deviation.Registration of the complaint and the analysis of the case: the defect shown in the picture shows us that the 30 mm hole is present and any large cut-out was secured to the maximum, so we classify the complaint as uncritical, because the patient can use the wafer from 30 mm to 43 mm.Corrective action(s) - no corrective action required, the defect on the bag cannot be corrected because is single-use product and besides does not need the correction because in all large the cuttability is guaranteed.Sensitization of the employees if the hole on the wafer does not move approved tolerance range to sort out the bags/wafer.Supplier investigation report attached to child investigation record.The investigation associated with related event record has been approved and was 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.Third party manufacturing site (for life): 3003759552.

Event Description

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

• Brand Name: ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 16181830
• MDR Text Key: 308458523
• Report Number: 1049092-2023-00007
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455197460
• UDI-Public: 00768455197460
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 421617
• Device Lot Number: 0000669835
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2022
• 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