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

Model Number	413181
Medical Device Problem Codes	Fluid/Blood Leak (1250); Malposition of Device (2616)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 16 of 17.A2: age at the time of event - 69 years.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.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
The end user reported that she had four market units of company¿s known precut opening wafers and one to four wafers in each box were off-centered.She was unable to specifically quantify the number from each box that was affected from four market units.She stated that, for the really bad wafers, she threw them out.However, on the ones that were not as bad, she would wear them but sometimes they caused her stoma to bleed due to trauma from the off-centered wafer.She mentioned that she had a condition that caused bleeding in general and that she had to be very careful.Also, shared that she received these off centered wafers so frequently that she was forced to use them and when she used them, she saw that her stoma became traumatized.She also got leakage on using the wafers with the off-centered openings.The product was used for two to three days.Also, the product was not returned.No photo was available at this time.
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.Returned sample evaluation: no photograph associated with this case was received for evaluation.Batch record review: the lot 2k00644 was manufactured on 09/oct/2022 convex 2-piece (pc) manufacturing line, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 21/jul/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 (b)(4) and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Investigation summary: this issue is related to off center issues.The scope of this investigation covers all product family manufactured in convex 2pc line.This complaint has been evaluated for mdr reportability using mdr procedure work instruction.The 30-day mdr reportability decision for this complaint is yes.The harm was reported with this complaint.The complaint as described has been reviewed and does not represent a threat to public safety and therefore does not warrant a 5-day report to the fda per 21 cfr part 803.This event is considered systemic based on the increase of complaints reported from 01/jan/2022 to 31/dec/2022, additional eleven (11) harm alert were reported by three different complainants and different period, in addition it was identified a nonconformance report before this investigation process.Based on that, actions will be taken to mitigate the failure mode reported.Refer to the process instruction (pi) and manufacturing lines impacted in this nonconformance below: convex 2-piece (pc) (process instruction (pi) convex 2-piece (pc) wafer sub-assembly machine 2 collaring operations).After 6 methodologies (ms) analysis was identified.Corrective and preventive actions will be taken for each of the causes identify for problem solution.Refer to corrective action / preventive actions (capa) plan record in database.The investigation has been approved and is complete.No additional action is required, and this complaint will be closed.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: 17018020
• Report Number: 9618003-2023-00626
• Device Sequence Number: 7168617
• Product Code: EXE
• UDI-Device Identifier: 00768455124510
• UDI-Public: 00768455124510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/12/2023

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: 413181
• Device Lot Number: 2K00644
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2022
• 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: Female