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

Model Number	413180
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 38 of 40.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.(b)(4).
Event or Problem Description
The end user reported that 40 out of 90 wafers from a total of 9 market units had off centered starter holes.The products were not used.A photograph depicting the issue was received from the end user.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Batch record review: lot 9k03700 was manufactured on 10/27/2019 in the convex 2pc line with a total of (b)(4).Complaint investigator performed a batch record review on 08/06/2020 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, under international commodity code (icc) code 413180 system application product (sap) material id 1161269 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photo related to the reported problem is available for evaluation.Investigation summary v.Investigation conclusion: material, method/process, manpower and measurement sections were reviewed, and it is considered none of them interfered on the incidence of the root cause, also, these sections and possible opportunities were previously covered.Based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented, the root cause for this failure mode was identified as machine.As observed during this investigation the contributor factors to this failure mode were the following: a) condition of the yamaha arm.B) condition of vision system cameras.C) variance in the materials, cause variation in the placement.This is causing the overall variation 0.6.This accumulation of variation causes the complaint in section 1.To maintain acceptable levels of variation the maintenance for the arm will be improved.And base on the rate of complaints and the variation identify, codes with a rate higher than 10 complaints per million will be block and manufactured on the improve convex 2 pc in building 8a.The investigation associated with related event 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.

• 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
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 10095003
• Report Number: 9618003-2020-11770
• Device Sequence Number: 14299675
• Product Code: EXE
• UDI-Device Identifier: 00768455124503
• UDI-Public: 00768455124503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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

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: 10/25/2024
• Device Model Number: 413180
• Device Lot Number: 9K03700
• 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: 05/05/2020
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown