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

Model Number 413521

Device Problems Obstruction of Flow (2423); Material Protrusion/Extrusion (2979); Material Too Soft/Flexible (4007)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2023-00283 / device 4 of 4.(b)(6).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).Manufacturing site:(b)(4).

Event Description

The end user reported that moldable mass swelled and covered stoma after one day or less of wear time.She had initially experienced the issue with first four pouches from the box at home and she had been used this company's device successfully since (b)(6) 2022 and felt it weird and but could not found any solution to resolve the issue.Her stool consistently was like thick sauce, not liquid.She had put the first fresh bag on, within few hours of application, she felt heaviness and pulling effect, although bag was not full and didn't even eat a meal at that time.Then, she went to check and observed that material that hugged the stoma inside was swelled right up and covered her protruding one or half inch stoma, due to which she changed it immediately as she didn't know what to do.She is a single woman in her fifties, weigh around 110 (weight units unknown) with height 5'7" and she is on disability due to which she does not want to just change a bag in a careless way.Although her diet was even and she was taking loperamide for months and didn't have any issues with thickening agents the day before, she observed there was no stool because the stoma opening was covered, and she was always used to look at window for proper connection of bag to the moldable center to make sure whether her stoma was placed right, but the event happened again and again.The day before she experienced an explosion in front of her family members, was never experienced by her before.She was quite happy with device with wear time of five days without any issues.But later on, when she wore the fourth pouch, she had to run to restroom all day to check since her stoma was right at the top of the swelling.Although stool could pass from stoma, but she changed before bedtime because of the risk of leakage.No photo was available at this time.

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 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 2h02719 was manufactured on 23 aug 2022 in the advanced planning and scheduling system (aps) 6 auto manufacturing line, with a total of 1,232 market units (mkus).On 02 jun 2023, compliance engineer 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 bill of materials (bom), under system application product (sap) material 1708122 and manufacturing order 1654216.The testing results were found satisfactory.Therefore, no discrepancy related to this issue were found within the documentation.In addition, bulk lot 2h0251001 sap material 1707112 manufactured in convatec moldable adhesive technology (cmt) line were reviewed and no issues found.Furthermore, bulk lots from in convatec moldable adhesive technology (cmt) 2g02871, 2g03059 & 2h01655 and sap material 1707789 & 1707790, were manufactured in elc #7, batch were reviewed, and no problems related to the failure mode were found.On 02 jun 2023, a complaint search for lot 2h02719 and malfunction code - skin barrier migrates and obstructs stoma, was carried out and as a result, no additional complaints were found; therefore, no potential trend was observed and this case was considered an isolated incident.As per complaint manufacturing investigation procedure work instruction (wi), it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend was identified (therefore, considered an isolated incident).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: 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: 16653398
• MDR Text Key: 313151537
• Report Number: 9618003-2023-00283
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455187812
• UDI-Public: 00768455187812
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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: 2H02719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2022
• 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
• Patient Sex: Female