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

Model Number 401933

Device Problem Sharp Edges (4013)

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

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 3.A2: age at the time of event - 53 years.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: 1049092, manufacturing site: 9618003.

Event Description

The end user reported that pouch flange was jagged and had pieces of plastic sticking out.It was not smooth.She tried one, but it leaked.She clarified that the flange groove where the wafer inserted was not cut correctly.In her opinion, the machinery used did not look like it was sharp enough to cut it deep enough or properly.She described it as a "bad hole punch".She wore one pouch where the plastic rubbed against her stoma because there was an outward projection of plastic.She felt that it irritated her stoma superficially but did not report bleeding or any signs of actual injury.No photo was 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 photograph, video and/or physical sample evaluation: ¿ no photograph associated with this case was received.No return sample has been received for this complaint.Batch record revision results: lot 3c06642 was manufactured on 11/apr/2023, in 11d line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 30/jan/2024, 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 identification (id) 1031504 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi).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 30/jan/2024, the complaint investigator ran a query in database in order to verify the complaints reported for 3c06642 lot for the malfunction ¿ skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿ and as result no additional type 2 complaints were identified during this search as per work instruction (wi).Historical nonconformance review: on 30/jan/2024, the complaint investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿ for the lot number 3c06642 and as result, no nonconformance / capa (s) for this malfunction 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: tm-020 "weld strength testing - pouches"- method 7: ¿ frequency: hourly ¿ sample quantity: 10 pouches ¿ acceptance criteria: accept = 1 | reject = 2 defect rate analysis: there have only been 2 defective parts confirmed to date from a lot size of 26,880 products.This represents a defect rate of only 0.007% which is well within an appropriate acceptable quality level (aql) for leakage which should be 1.0% 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 aql of 1.0 this issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted 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 3c06642 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 nonconformity has been registered during the manufacturing process of the affected lot for the malfunction "skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿.No additional complaints were reported for lot affected related to the malfunction ¿skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿.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.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted aql level for this type of failure mode or defect.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.

Event Description

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

• Brand Name: NATURA
• 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: 18579213
• MDR Text Key: 333725787
• Report Number: 9618003-2024-00059
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455183302
• UDI-Public: 00768455183302
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 401933
• Device Lot Number: 3C06642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2023
• 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