MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN

Device Problem Insufficient Information (3190)

Event Date 11/01/2023

Event Type  Injury  

Event Description

The notification form stated: "stimulan beads inserted during operative procedure, patient subsequently developed severe hypercalcemia which required emergency management.".

Manufacturer Narrative

Two emails have been sent to the reporting ca.One requesting further paitent and submitter details, this request was denied due to no permission to submit details.Second email was requests for further information on the device types, size and any mxiing information.No further correspondence.No further invesitgations can be planned.On-going monitoring of incidents and events shall be conducted as per quality system.

• Brand Name: STIMULAN
• Type of Device: STIMULAN
• Manufacturer (Section D): BIOCOMPOSITES LTD; ic4; keele, science park; stoke-on-trent, staffordshire ST55N L; UK ST55NL
• Manufacturer (Section G): BIOCOMPOSITES LTD; ic4; keele, science park; stoke-on-trent, staffordshire ST55N L; UK ST55NL
• Manufacturer Contact: kirsty-louise marrow ; ic4; keele, science park; stoke-on-trent, staffordshire ST55N-L ; UK ST55NL
• MDR Report Key: 18674904
• MDR Text Key: 335004481
• Report Number: 9617083-2024-00001
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 40 KG