MAUDE Adverse Event Report: Biocomposites Ltd. Stimulan; Rapid Cure

Lot Number	SR251118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypercalcemia (4822)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented in hospital with high levels of calcium (20.1 mg/dl) and confusion.During admission.The patient was treated with continuous intravenous fluids, calcitonin 340 units x3 doses, and 1 dose zolendric acid for the treatment of hypercalcemia.

• Brand Name: Stimulan
• Common Device Name: Rapid Cure
• Manufacturer (Section D): Biocomposites Ltd.; ic4 keele science park; keele, staffordshire, gbr ST55N L; UK ST55NL
• MDR Report Key: 50777994
• Report Number: 3003029518-2026-00003
• Device Sequence Number: 10664471
• Product Code: MQV
• UDI-Device Identifier: 15060155711048
• UDI-Public: 15060155711048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026
• Report Date (Section F): 09/15/2026

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
• Device Lot Number: SR251118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2026
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 80 LB
• Patient Race: White