MAUDE Adverse Event Report: UNOMEDICAL S.R.O. ESTEEM; BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

Model Number	423665
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional 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.Fda registration number.Reporting site: 1049092.Manufacturing site: 3005778470.
Event or Problem Description
The end user reported that she felt that the convexity of the pouch was too firm and cuts into her stoma when she bends.She stated that her stoma would ooze with a small amount of bleeding when she bends, which however resolved quickly.She tried the 3.5-millimetre (mm) depth prior and felt that it was more comfortable.No photo is available at this time.
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: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Based on the available information, this event is deemed to be a reportable malfunction.No photo has been received for this complaint.A batch record review indicates no discrepancies.Ileostomy bags in question were manufactured under international commodity code (icc), system application product (sap) material identification (id) 1737576 and manufacturing lot #5f04195.Order (b)(4) was produced in june 2025 on machine a221, with lot amount (b)(4) pcs.The production process, in-process control, testing result, packaging of products was run according to the process instruction (pi) for esteembody drainable pouches and recorded in batch record (br) instruction.During production were used collars system application product (sap) 1737393 - convex baseplate flex v1 ctf 10-45 mm, lot 5f01073 and 5d05569.Collars were produced in accordance with process instruction (pi) pi pre baseplate na k55/mme2 and all measuring and control are recorded in batch record (br) instruction.During production of product lot 5f04195 were used all the right components.Review of the device history record (dhr) showed that all relevant tests required during manufacturing process and final product release had been fulfilled and met the requirements.No nonconformance has been registered during the manufacturing process of the affected lot and of the mention issue.No similar complaints related to ¿pouch materials in contact with skin are too rough or sharp¿ was received on mentioned lot 5f04195.No samples, photograph or relevant objective evidence has been received for this complaint.Affected quantity is 1 pc / lot size (b)(4) pcs, which represent (b)(4).We can not perform deeper investigation without relevant objectives evidence.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 3005778470.

• Brand Name: ESTEEM
• Common Device Name: BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 23777084
• Report Number: 3005778470-2025-00854
• Device Sequence Number: 10170760
• Product Code: FON
• UDI-Device Identifier: 00768455204144
• UDI-Public: 00768455204144
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Model Number: 423665
• Device Lot Number: 5F04195
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female