MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+; POUCH, COLOSTOMY

Model Number 413521

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The end user had problems with this lot.The moldable disc seemed thinner and more dry than usual.It cracked when he tried to mold.It caused leakage for him during wear time - usually he could wear a bag for 24 hours.

Event Description

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

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.Batch record review: lot 1e00743 was manufactured on 26/may/2021, in the aps 6 automated manufacturing line with a total of (b)(4) market units (mkus).Complaint investigator performed a batch record review on 12/aug/2022, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, sap material id (b)(4) and manufacturing order (b)(4).No discrepancies related to the issue reported were found.The disc used in the manufacturing process of batch 1e00743 was the part number 1707112 (disc esteem s/hesive moldable cmt 20/30), bulk lot 1e02077, manufactured in the cmt manufacturing line under procedure instruction (pi).All the components used were correct per bom and all the tooling information documented was also correct.No discrepancies related to the issue reported were found.Historical complaints review: on 28/jul/2022, complaint investigator ran a query in database in order to verify the complaints reported for the batches listed in the table and as result, a total of two (2) complaints were found reported.However, only one of these complaints was related to the malfunction code involved in this investigation.Returned sample evaluation: no photographs associated with this case and no unused return sample was expected.Conclusion: based on the preliminary investigation performed, no issues related to the customer experience were found in the batch record review.No significant changes have been made in the process or in the product components that could cause the adverse effects reported by the customer.The product was used in their shelf life.No photos or samples were received and per customer description there was not enough information about how the product was used that leads us to a conclusion, therefore, there was not product malfunction confirmed.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: L3O0675 - ESTEEM+
• 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: 13658036
• MDR Text Key: 288853483
• Report Number: 9618003-2022-00246
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 413521
• Device Lot Number: 1E00743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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: Male