MAUDE Adverse Event Report: BSN MEDICAL INC. DELTA-CAST® SERENE; CAST REMOVER

Model Number	76289-08
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial investigation of returned device indicates the product performs according to specification.Product will be returned to contract manufacturer for further investigation.
Event or Problem Description
During a demonstration session, one of the members of the casting staff was using the cast remover to remove a cast from the arm of a colleague.During the removal, the colleague with the cast indicated they were experiencing pain in their arm.The user stopped use of the device and backed the device out.After the cast had been removed, a bruise with a small cut was visible.A later taken picture of the area showed an approximately 2 cm long tear of the skin.The individual visited occupational health for a tetanus and hepatitis b vaccine.
Additional Manufacturer Narrative
Device was returned and received by the contract manufacturer for additional evaluation on may 12, 2025.Report issued may 22, 2025, indicates device performs according to specification.Note: as reported in the initial report, initial investigation of returned device was conducted by the specification developer.Date of this evaluation was not present in the initial report; initial evaluation was conducted (b)(6) 2025.As noted in the initial report, this evaluation indicated the product performs according to specification.Following this investigation the device was returned to the contract manufacturer for further evaluation.As noted above, this evaluation also found the product to perform according to specification.

• Brand Name: DELTA-CAST® SERENE
• Common Device Name: CAST REMOVER
• Manufacturer (Section D): BSN MEDICAL INC.; 5825 carnegie blvd; charlotte NC 28209
• Manufacturer (Section G): DISRUPTIVE MEDTECH, LLC; 3821 beech st; laramie WY 82070
• Manufacturer Contact: drew zhou ; 5825 carnegie blvd; charlotte, NC 28209 ; 8457453574
• MDR Report Key: 21913715
• Report Number: 1038963-2025-00001
• Device Sequence Number: 16139497
• Product Code: LGH
• UDI-Device Identifier: 04042809876253
• UDI-Public: 4042809876253
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 76289-08
• Device Lot Number: 00397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male