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

Model Number 404594

Device Problem Material Separation (1562)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-06798/ device 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 Description

This emdr is for an unknown additional quantity of wafers as reported by the end user.The end user reported as a result of trying the wafers he had an area approximately 13mm in size that was rubbed raw.According to the end user, the separation exposed the plastic piece and the plastic piece then rubbed against his skin.The end user stated that small amount of blood was weeping, but bleeding resolved without intervention, it resolved by itself and no treatment was required.The end user stated he did have a bulge behind his stoma and area around it was firm.The flat flexible appliance was recommended.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).The investigation associated with related event (b)(6) 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,(b)(4).Batch record review: the batch record review supports that there were no discrepancies related to the issue reported.This batch was manufactured following the applicable procedures, all machine and testing parameters were in accordance with the applicable procedures and specifications, the testing results were found satisfactory and no nonconformance related to the malfunction code in analysis was noted.The line clearance was executed per (b)(4) ¿procedimiento de despeje de línea y chequeo de seguridad¿, the results were documented, and no issues were identified during the manufacturing process.The materials comply with the correct parameters, pi, ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Executive summary of the nc: based on the results of the preliminary investigation, the batch record reviews were performed, and no discrepancies were found.A revision of the improvements made to the process was performed, and actions have been implemented for this type of incidents.The last batch received was manufactured prior to the implementation of these improvements.Furthermore, a complaints search conducted shows that no adverse trend was identified from january 2018 to august 2020 for this failure mode.This failure mode will keep monitoring for track and trending.Based on the explanation above, no additional investigation is needed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

To date no additional patient or event details have been received.

• Brand Name: NATURA
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 9302342
• MDR Text Key: 166144313
• Report Number: 9618003-2019-06798
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Model Number: 404594
• Device Lot Number: 9D03890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1