MAUDE Adverse Event Report: CONVATEC EAKIN; BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

Model Number	839002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Itching Sensation (1943); Fungal Infection (2419); Tissue Breakdown (2681); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Dry Skin (4839)
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user reported that the product caused him to develop yeast infection around the stoma.He also reported skin irritation with mirror image of redness in the shape of the company's seal around the stoma with itching and small amount of bleeding.He stated that the skin looked chapped.The product was used for one to two days.Doctor of medicine (md) prescribed two antibiotics for this for thirty days and a topical antifungal powder.The end user reported that his skin improved with other company's rings because they don't break down and dissolve like company's seal.The end user used other company's rings and adamant that the company's seal caused the issue.He later ran out of another company's seal and went back to use company's seal and skin irritation returned.No photograph is available at this time.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.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, third party manufacturing site: 9681410.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings & investigation conclusions.Type of investigation: 3331 - 11 - 4114.Investigation findings: 213 - 4256.Investigation conclusions: 67.This complaint has been evaluated and supplier response was as follows: a batch record review indicates no discrepancies.The supplier eakin, confirmed their quality team has investigated thoroughly the production records and has carried out extensive testing of the retained samples for batch c152 and found the product to be conforming.As result of the investigation, there has been no fault found with this batch and it is confirmed that the chemical composition is identical to reference batches.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.Third party manufacturing site: 9681410.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: EAKIN
• Common Device Name: BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
• Manufacturer (Section D): CONVATEC; 7900 triad center drive; suite 400; greensboro NC 27409
• MDR Report Key: 17441176
• Report Number: 1049092-2023-00225
• Device Sequence Number: 11447086
• Product Code: FON
• UDI-Device Identifier: 00768455108732
• UDI-Public: 00768455108732
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023
• Report Date (Section F): 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 839002
• Device Lot Number: 109357C152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2023
• Date Report to Manufacturer: 07/31/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 01/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male