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

Model Number	423646
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is considered misuse.Per the information for use (ifu), the patient had been cutting away the mass from the stoma opening at the distal end since experiencing this issue, despite being advised that her current pouching system was not designed to be cut to fit.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, manufacturing site: 3005778470.
Event or Problem Description
The end user reported that she developed a cut to her stoma, which she was unable to visualize.She experienced bleeding from the area while removing the pouching system.She saturated five baby wipes with this bleeding event.After reapplying her pouching system, the bleeding resolved.She had been cutting away the mass from the stoma opening at the distal end since experiencing this issue, despite being advised that her current pouching system was not designed to be cut to fit.She denied having a hernia or bulge.She used one appliance out of a box of ten.She contacted her surgeon, who advised her to come into the office.During her visit, the surgeon cauterized the area, although she was unsure of the method used as she was lying down at the time.No further bleeding was noted.She didn't wear an ostomy belt, wrap, or abdominal binder and prefers a pre-cut system.Her ileostomy stoma protrudes half to one inch.She could not confirm the stoma size but mentioned that the current size was perfect for her.She was advised to switch to a larger size or a cut-to-fit pouching system and to measure her stoma to ensure it still measured twenty-five millimeter (mm).No photograph was available at this time.
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: a batch record review indicates no discrepancies.No photograph has been received for this complaint.A batch record review was conducted resulting in the following: ileostomy bags in question was manufactured under reference code 423646 / system application product (sap) material identification (id) 1737655 and manufacturing lot # 4d01537.Order (b)(4) was produced on april 2024 on center c5 on machine a221, with lot amount (b)(4) pieces (pcs).The production process, in-process control, testing result, packaging of products was run according to the process instruction process instruction (pi) for esteembody drainable pouches and recorded in batch record (br).Customer reports noting bleeding from the area when she removed her pouching system.She has been cutting away the mass from the stoma opening at the distal end since experiencing this issue.Product has pre-cut system of collar.However, the patient should, according to the instructions for use (ifu) check for sharp edges on the skin barrier before applying the pouch.During production of this lot, pouches were visually controlled using: test methods (tm) visual nonconformities - laminated adhesive products.All products must have acceptable appearance.Review of the device history record (dhr) showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.The process parameters were adjusted within the validated window.Because there was no indication of the issue occurrence found either test performing or records in the logbook the cause of the defect cannot be determined.No nonconformity has been registered during the manufacturing process of the affected lot and of the mentioned issue.No other similar complaint related to issue was received on mentioned lot 4d01537.During production of product international commodity code (icc): 423646, lot 4d01537, were used all the right components.This investigation 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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: ESTEEM BODY
• 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: 21191016
• Report Number: 3005778470-2025-00010
• Device Sequence Number: 3467543
• Product Code: FON
• UDI-Device Identifier: 00768455203956
• UDI-Public: 00768455203956
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2026
• Device Model Number: 423646
• Device Lot Number: 4D01537
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female