MAUDE Adverse Event Report: ADVANCED MEDICAL BALLOONS GMBH HYGH-TEC; TUBES, GASTROINTESTINAL

Model Number	V01-10024
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Pressure Sore/Ulcer (2326)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned by the user facility for evaluation.For the affected batch 2414001 (production date: 04/02/2024; expiry date: 04/02/2026), a batch record review was conducted.No deviations, nonconformities, or anomalies related to manufacturing, packaging, or release were identified.Although the initial reporter indicated an expiration date of 09/01/2025, review of the batch records confirmed that the correct expiration date for batch 2414001 is 04/02/2026.In addition, an evaluation of post market data confirmed that no further complaints were received for batch 2414001.Based on the batch record review and the absence of additional complaints, there are no indications that the product was defective or failed to meet specifications.
Event or Problem Description
On 27-oct-2025, the manufacturer received a voluntary fda form 3500 submitted by the reporter.According to the information provided, the patient had a fecal management system (fms) in place.The initial system was placed on [redacted] and removed four days later.A new fms was placed on the same day and removed on [redacted], two days later, due to reported balloon air leakage and system leakage.Upon removal, the patient was noted to have a pressure injury on the rectum, which the reporter believed to be associated with the hard plastic component of the fms.The reporter was contacted and provided the following details: no medical intervention was needed other than wound care.Skin affected, pt reported 10/10 pain level.Additional attempts were made to obtain further details including clarification of the wound care required; however, the reporter declined to provide any additional details.

• Brand Name: HYGH-TEC
• Common Device Name: TUBES, GASTROINTESTINAL
• Manufacturer (Section D): ADVANCED MEDICAL BALLOONS GMBH; bruchsaler strasse 22; waghaeusel, baden-wuerttemberg 68753 ; GM 68753
• Manufacturer (Section G): ADVANCED MEDICAL BALOONS GMBH; bruchsaler strasse 22; waghaeusel, baden-wuerttemberg 68753 ; GM 68753
• Manufacturer Contact: michael rothhaar ; bruchsaler strasse 22; waghaeusel, baden-wuerttemberg 68753 ; GM 68753
• MDR Report Key: 24161326
• Report Number: 3015237508-2025-01027
• Device Sequence Number: 9001150
• Product Code: KNT
• UDI-Device Identifier: 04260566430116
• UDI-Public: 04260566430116
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: V01-10024
• Device Catalogue Number: V01-10024
• Device Lot Number: 2414001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic