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

Model Number 416976

Device Problems Fluid/Blood Leak (1250); Material Too Rigid or Stiff (1544); Positioning Problem (3009)

Patient Problems Abrasion (1689); Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Event Description

This emdr is being submitted for ten appliances from one market unit with company's known lot.The end user reported that the hard plastic ring with belt tabs was irritating her skin and the pouch leaked at that time.Further, she stated that the belt tabs rubbed her skin near the hernia.She denied injury or associated redness and stated that she cut the belt tabs off.In addition to this, she mentioned that despite cutting the tabs away, the skin barrier was less flexible and did not seal as it did before to her uneven contours and experienced reduced wear time from two - three days to two to six times daily appliance changes.The skin care routine of end user was followed with cleansing the skin with warm water and dial soap and using company¿s known sting-free adhesive remover wipe, sting-free skin barrier wipe and protective powder as needed.Furthermore, she reported that the pouch was worn vertically, and emptied when one/third full and denied use of standard ostomy belt, wrap or support device.Customer was seeking alternative product without hard plastic ring and alternate samples was also sent to her.No photo is available at this time.

Manufacturer Narrative

Device 5 of 10.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

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.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 2c05183 was manufactured on 19 /apr/2022, in 23a line, with a total of (b)(4) market units (mkus).The compliance engineer performed a batch record review on 27/sep/2023, 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, system application product (sap) material id 1728755 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction and recorded in br31-063 ver.64.0.Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Historical complaints review: on 27/sep/2023, compliance engineer ran a query in database in order to verify the complaints reported for the 23a manufacturing line for the malfunction code for pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿ and as result no additional type 2 complaints were identified during this search as per work instruction (wi).Historical nonconformance review: on 27/sep/2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction code for pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿ for the lot number 2c05183 and as result, no nonconformance / corrective action / preventive actions (capa) (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test method (tm) 014 ¿visual pouch non-conformities¿: frequency: 80 times per shift (10 per hour).Sample quantity: (b)(4).Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 10 defective parts confirmed to date from a lot size of 62640 products.This represents a defect rate of only (b)(4) , which is well within an appropriate acceptable quality level (aql) for leakage which should be (b)(4) based on our standard operating procedure (sop) ¿quality inspection plan¿.In addition, all the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of 0.25.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: no objective evidence was received such as a photo or sample, for this reason, we cannot conclude that the product does not meet specifications.The review of the batch record for lot 2c05183 showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No changes to the end-to-end manufacturing process or components used during assembly of the batch were made.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code for pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿.No additional complaints were reported for lot affected related to the malfunction for pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products from this lot are impacted, and the issue appears to be isolated.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 16251732
• MDR Text Key: 308581771
• Report Number: 9618003-2023-00161
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416976
• Device Lot Number: 2C05183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2022
• 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