MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; PROTECTOR, OSTOMY

Model Number	411800
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that a portion of mass dissolved revealing the plastic liner in one wafer out of sample pack of three.He stated that the plastic liner had been in contact with his stoma and caused irritation and a trace amount of blood from his stoma.The bleeding did not continue, and he did not have to apply pressure to the area or seek medical treatment.This was the first time the consumer had used this wafer.He had the wafer on application for four days and had been using the current product for less than four months.He further stated that he had worn a similar company¿s wafer without any issue, and he will continue to use the same.No photo was available at this time.
Additional Manufacturer Narrative
(b)(4).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 (b)(4).
Additional 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 1j02896 was manufactured on 10/4/2021, in ats #2 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 1222276 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 br31-144 ver.5.0.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 1j02896 lot for the malfunction code ¿film layer exposed (i.E., moldable skin barrier layers separate or delaminate from inner film layer)¿ and as result, no additional type 2 complaints were identified during this search as per work instruction.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 ¿inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer)¿ for the lot number 1j02896 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: br31-144 section 3.0 ¿dimensional verification and visual inspection¿: frequency: 24 times per shift (3 per hour).Sample quantity: 1 piece per head and 3 per hour.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 1 defective part confirmed to date from a lot size of 29400 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) ¿quality inspection plan¿.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 for lot 1j02896 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 ¿inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer)¿.No additional complaints were reported for lot affected related to the malfunction code ¿inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer)¿.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.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: PROTECTOR, 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 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: 15527221
• Report Number: 9618003-2022-04948
• Device Sequence Number: 16816807
• Product Code: EXE
• UDI-Device Identifier: 00768455187003
• UDI-Public: 00768455187003
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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 Expiration Date: 09/03/2026
• Device Model Number: 411800
• Device Lot Number: 1J02896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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: Male