MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA+; BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

Model Number	416416
Medical Device Problem Codes	Fluid/Blood Leak (1250); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 3 of 4 based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: there were photographs associated with this case; however, the reported defect cannot be seen.No unused return sample was expected.Batch record revision results: lot 4g01162 was manufactured on 04/jul/2024, in aps 4 auto line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 06/jun/2025, 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) 1703524 and manufacturing order (b)(4).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 was found within the documentation.Historical complaints review: on 06/jun/2025, complaints investigator ran a query in database in order to verify the complaints reported for the 4g01162 lot for the malfunction "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)" defect and no additional complaints were identified.Historical nonconformance review: on 06/jun/2025, complaint investigator ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction "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 4g01162 and as result, no nonconformance / corrective and preventive actions (capa) (s) for this malfunction were generated during the manufacturing process of the referenced lot.Defect rate analysis: there have only been 4 defective parts confirmed to date from a lot size of (b)(4) 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 0.25% based on our standard operating procedure (sop).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 importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: the batch records have been reviewed and all necessary tests during the manufacturing process and final product release have been completed and met the requirements.Additionally, a review of historical nonconformances showed no additional nonconformances.It's important to note that the failure rate is well within our accepted acceptable quality level (aql) level for this type of 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 or Problem Description
The end user reported four pouches outlet strips were cracked, she stated this issue occurred on second day of use.She started using the pouches that have the straight outlet strips and started to get leakage.She was unsure if the leakage was coming from between the outlet strip and the seam around the outlet strip or if it occurred because the outlet strips become sharp and punctured the pouch film when it was folded up which she had visualized.It started with the strip cracked and broken into pieces that were sharp like paper cuts.The end user reported that this was the fourth pouch out of this box that this had happened with.The first three were not as bad as this issue and she was not sure if it was a leak or happened by some dropped stool on the toilet seat.The product was used by the patient.Photographs depicting the issue were received from the complainant.

• Brand Name: NATURA+
• Common Device Name: BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
• 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; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 22283610
• Report Number: 9618003-2025-02005
• Device Sequence Number: 8893292
• Product Code: FON
• UDI-Device Identifier: 00768455188079
• UDI-Public: 00768455188079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 416416
• Device Lot Number: 4G01162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• 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 Age: 69 YR
• Patient Sex: Female