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

Model Number	413179
Medical Device Problem Codes	Material Erosion (1214); Melted (1385)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that the mass immediately surrounding the stoma melted away and the clear plastic film covering the mass remained and it cut his stoma on the left side where he bended.The cut was small approx.3/8" long and slightly deeper than a paper cut.He did have a small amount of bleeding from the area with the change which resolved without intervention.When he does the change he first applies a another company's seal and "molds" it to the sides of his stoma and then applies our company's product and wafer stoma opening allows for 1/32 to 1/16" of skin between the stoma and the opening.Usual wear time was four days.He had worn this wafer for some time and not experienced this issue in the past.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Other company's product: coloplast brava seal a2: age at the time of event - 71 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.
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 h10: investigation summary 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 3h00924 was manufactured on 8/07/2023, in convex 2 pc line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 01/mar/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) 1161268 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 01/mar/2024, the complaint investigator ran a query in database in order to verify the complaints reported for 3h00924 lot for the malfunction code ¿inner 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 (wi).Historical nonconformance review: on 01/mar/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 code ¿inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer)¿ for the lot number 3h00924 and as result, no nonconformance / malfunction code capa (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Conclusions: the review of the batch record 3h00924 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 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.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.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: 18737320
• Report Number: 9618003-2024-00130
• Device Sequence Number: 17949275
• Product Code: EXE
• UDI-Device Identifier: 00768455124497
• UDI-Public: 00768455124497
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/26/2024

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: 413179
• Device Lot Number: 3H00924
• 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): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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