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

Model Number 413181

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Device 6 of 10.Based on the available information, this event is deemed to be a serious injury.No product malfunction is considered for this emdr as bowel obstruction may have contributed to fungal infection issue.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number (b)(4).

Event Description

The end user stated she developed fungal infection under her wafer and over her stomach as a result of the stool leakage.She was prescribed oral antibiotic and nystatin powder for fungal infection which was resolved later.Ostomy nurse suggested one-piece other company¿s pouch while her skin was healing which led to no leakage issues with product.She stated that the product was used for eight to nine months with three-day wear time.She also had developed a bowel obstruction last week which was not related issue to company¿s product that is resolving.Abdomen was distended for about one day, and this did not cause the decreased wear time.The product was used on patient.No photo is available at this time.

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 h6: imdrf investigation findings : c24 is captured for the issue malfunction observed without conclusive finding an investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Lot 2e00207 was manufactured on 05/04/2022 and this was the only complaint found in database.Hence, no full cause investigation was carried out.No return samples were provided.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 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: 15484609
• MDR Text Key: 300571646
• Report Number: 9618003-2022-05089
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 00768455124510
• UDI-Public: 00768455124510
• 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
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413181
• Device Lot Number: 2E00207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female