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

Model Number	125259
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial 1 of 2.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 stated that when he took the wafer out of the blister pack, the wafer appeared stiffer than usual.The plastic was reported to be hard and almost rigid.He felt like this might have contributed to the poor wear time.His usual wear time was 7 days but it had to be changed after 2 hours.The reported wafer lasted around four hours before blowing off.
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: d4: unique identifier (udi).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 were received and no unused return sample was received for evaluation.Conclusion summary of the related event: based on the results of the preliminary investigation, the batch record review was performed, and no discrepancies were found.In addition, no photo or sample were received confirming the defect by customers.Furthermore, through the process investigation it was concluded that the reported issues may be associated to the mixing process.The root cause investigation was generated, and corrective and preventive actions were taken through the capa plan that could impact in this failure mode.Furthermore, based on the analysis of the complaint data, no adverse trend was observed for the failure mode in the involved lines.For all the explanation above, a root cause investigation (rci) is not necessary.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: 9277097
• Report Number: 9618003-2019-05767
• Device Sequence Number: 2734476
• Product Code: EXE
• UDI-Device Identifier: 00768455125388
• UDI-Public: 00768455125388
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 02/05/2024
• Device Model Number: 125259
• Device Lot Number: 9B04172
• 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: 10/11/2019
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 09/04/2023
• 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: Male