MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN; STIMULAN RAPID CURE

Lot Number SR190501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

The surgeon does not know the cause of the fever.Potential causes include persistent infection (as the patient had a series of procedures over 2 months), high antibiotic powder usage or an allergic reaction.Symptoms stopped after a surgery to remove metalwork and perform flap revision, during which all stimulan was removed.Stimulan and genex products are not believed to be the cause of the adverse reaction.Manufacturer states that this was off-label use, due to use of abx.

Event Description

Potential adverse incident.He hopes to be able to speak to the surgeon to ask some questions as (b)(6) so far has been the "middle man" and we do not have much information.However, it seems there was drainage and the patient (child) had a high temperature) following surgery, which may indicate persistent infection.Stimulan and genex were used, along with vanc, gent and meropenem.The surgeon re-operated and removed all metalwork as well as any remaining genex or stimulan.

• Brand Name: STIMULAN
• Type of Device: STIMULAN RAPID CURE
• 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: 18711251
• MDR Text Key: 335525276
• Report Number: 9617083-2024-00002
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/31/2022
• Device Lot Number: SR190501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VANCOMYCIN, GENTAMYCIN, MEROPENEM.
• Patient Outcome(s): Hospitalization