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

Model Number	421040
Medical Device Problem Codes	Melted (1385); Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the end user that six to ten months back, nearly in 80% of the wafers had an off-centered starter hole.He used the product for past six years.He believed this is due to insufficient quality control issues.He also, stated that due to starter hole being off-centered, when he molded the wafer to stoma size, one side of the wafer ended up being thicker than the other side and coming apart.Additionally, reported that the sticky part as stringy melted cheese.He normally would change his wafer every four to five days prior to this issue, but now had to change after every four days.He changed his pouch every other day per preference and because the stringy part of the wafer sticking to it.The product was used on patient.No photograph was available at this time.
Additional Manufacturer Narrative
Mdr 9618003-2024-01924 / device 6 of 9 a2: age at the time of event - 73 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.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.Photograph, video and/or physical sample evaluation: no photographs were received for this issue for evaluation in accordance with work instructions (wi).No samples were available for this complaint, and therefore it was not possible to confirm the complaint.Batch record revision results: lot 4a00070 was manufactured 1/2/2024, in ffs #1 line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 26/apr/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) 1709735 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 were found within the documentation.Historical complaints review: on 26/apr/2024, complaints investigator ran a query in database in order to verify the complaints reported for the 4a00070 lot for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect and no additional complaints were identified.Historical nonconformance review: on 26/apr/2024, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect for the lot number 4a00070 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.Defect rate analysis: there have only been 8 defective parts confirmed to date from a lot size (b)(4) products.This represents a defect rate of only 0.018%, which is well within an appropriate acceptable quality level (aql) for this defect which should be 0.25% based on our standard operating procedure (sop).In addition, all of 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.To date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: as no photographs or samples were available for this complaint issue, it was not possible to raise an investigation for the issue reported.A batch record review was completed and 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.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.

• 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 27409 ; 3365424679
• MDR Report Key: 19297018
• Report Number: 9618003-2024-01924
• Device Sequence Number: 15198738
• Product Code: EXE
• UDI-Device Identifier: 00768455133826
• UDI-Public: 00768455133826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 05/13/2024

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: 421040
• Device Lot Number: 4A00070
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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: 73 YR
• Patient Sex: Male