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

Model Number	411804
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 13 of 13.(b)(6).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
It was reported by end user that the starter hole of thirteen skin barriers was slightly off centered.The product was not used by end user.There was no harm reported.The photographs depicting the issue were received from the complainant.
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 batch record review: the batch 7g04286 was manufactured on 03/aug/2017, ats #2 manufacturing line, complaint investigator performed a batch record review on 30/dec/2022 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 1222278 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: two photographs associated with this case was received.No return sample has been received for this complaint.Complaint data analysis: on 30/dec/2022, complaint investigator performed a search of complaints into database system for lot number 7g04286.As a result, a total of one complaint was found and only one is related to the same malfunction code of this investigation.Conclusion summary of the related event: based on the preliminary investigation, no irregularities / discrepancies were found in any of the batch records reviewed.In addition, a complaint search performed in database system by manufacturing date for the ¿starter hole off center or misaligned¿ failure mode for ats#1 and ats#2 manufacturing lines shows a decreasing trend from jun 2019 to date (cut off 30/sep/2020).As part of the nonconformance report (ncr) actions were taken for this failure mode, which were the main factors for the reduction in the quantity of complaints per month.Furthermore, a nonconformance search was performed in database system, from 2018 to 30/sep/2020, for the ¿starter hole off center or misaligned¿ failure mode for ats#1 and ats#2 manufacturing lines and as a result, no events related to this malfunction were found.Moreover, the following quality and manufacturing controls are currently in place, according to the product instructions and test methods, which contribute directly to the detection activities: ¿ manufacturing process instructions (pi - ats1 assembly and packaging / pi - ats2 assembly and packaging) 1.Visual inspection to completed product 100% of units 2.Testing and inspection log ¿ dimensional verification and visual inspection looking for collar concentricity ¿ 6 samples at the beginning of the batch and each one hour ¿ quality test methods (tm - visual nonconformities laminated adhesive products / tm - pouch nonconformities) additionally, a new quality notification was given to the quality and manufacturing personnel of the ats#1 and ats#2 manufacturing lines, to make them aware of the new complaints received for this failure mode for everything explained above, no additional actions are required.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 15742272
• Report Number: 9618003-2022-05322
• Device Sequence Number: 5660636
• Product Code: EXE
• UDI-Device Identifier: 00768455187041
• UDI-Public: 768455187041
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 08/02/2022
• Device Model Number: 411804
• Device Lot Number: 7G04286
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 12/31/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2017
• 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: Unknown