MAUDE Adverse Event Report: BIOCOMPOSITES LTD. STIMULAN RAPID CURE

Model Number	620-010
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bipolar removed because of infection.No other information available.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).Fda mdr report #: mw5180064.

• Brand Name: STIMULAN RAPID CURE
• Common Device Name: STIMULAN RAPID CURE
• Manufacturer (Section D): BIOCOMPOSITES LTD.; ic4 keele science park; keele, staffordshire, gbr ST55N L; UK ST55NL
• MDR Report Key: 24193260
• Report Number: 3003029518-2026-00002
• Device Sequence Number: 18116236
• Product Code: MQV
• UDI-Device Identifier: 15060155711031
• UDI-Public: 15060155711031
• Combination Product (Y/N): N
• 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): 01/27/2026
• Report Date (Section F): 01/27/2026

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
• Operator of Device: Health Professional
• Device Model Number: 620-010
• Device Catalogue Number: 620-010
• Device Lot Number: SR240611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/27/2026