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

Model Number 404594

Device Problems Material Separation (1562); Sharp Edges (4013)

Patient Problems Laceration(s) (1946); Tissue Damage (2104); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

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

The patient reported that the outer edge of mass was off-centered.Due to this, there was a small sharp edge of plastic exposed which in the past, had caused her to develop slits or cuts on her skin.This led to minor bleeding at the site, which she then covered with a small amount of stomahesive paste and another wafer.These cuts occurred on her skin under the outer edge of the mass, not her stoma.She had started applying stomahesive paste to the back of her wafers to cover the sharp edge, which prevented any new cuts recently.Picture of the alleged malfunction was provided by the end user.The exact quantity is unknown as the end user reported this as ¿several wafers¿ from 1 market unit.

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 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 (line clearance procedure and safety check)¿, the results were documented, and no issues were identified during the manufacturing process.The materials comply with the correct parameters, process instruction (pi), ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: there are photographs associated with this case.No unused return sample was expected.Executive summary of the non-conformance (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.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.

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
• 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: 9325908
• MDR Text Key: 170802747
• Report Number: 9618003-2019-08833
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2023
• Device Model Number: 404594
• Device Lot Number: 8H04517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female