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

Model Number	401513
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint was received by the retailer who further received information from the end user about pouch outline not smooth (redundant fiber) and had rough or sharp edge which caused skin irritation.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Initial reporter name and address : (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.(b)(4).
Additional Manufacturer Narrative
Photograph, video and/or physical sample evaluation: ¿ there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Batch record revision results: lot 2d03837 was manufactured on 10/may/2022, in 11e line, with a total of (b)(4) market units (mkus).The compliance engineer performed a batch record review on 18/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 1003654 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.14.0.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 18/sep/2023, compliance engineer ran a query in database in order to verify the complaints reported for the 11e 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 complaints were found.Historical nonconformance review: on 18/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 2d03837 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) -002 ¿visual inspection¿ ¿ method 8: ¿ frequency: all manufactured units.¿ acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 5 defective parts confirmed to date from a lot size of 8960 products.This represents a defect rate of only (b)(4), which is well within an appropriate acceptable quality level (aql) for this defect which should be (b)(4) based on our standard operating procedure (sop).In addition, all of the in-process testing on this lot did not find a single defective pouch, 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: the 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 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 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)¿.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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: NATURA
• Common Device Name: 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: 16302390
• Report Number: 9618003-2023-00220
• Device Sequence Number: 6792083
• Product Code: EZQ
• UDI-Device Identifier: 00768455182527
• UDI-Public: 00768455182527
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 401513
• Device Lot Number: 2D03837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown