MAUDE Adverse Event Report: ELOQUEST HEALTHCARE, INC. / FERNDALE LABORATORIES, INC. MASTISOL LIQUID ADHESIVE; TAPE AND BANDAGE, ADHESIVE

Model Number 00496052348

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  Injury  

Event Description

I recently learned that mastisol liquid adhesive is misbranded as being sterile when, in fact, the solution is not sterile.Instead, only the external packaging is sterile.This is a concern because i use this near and around an open iv catheter insertion site.Their literature does not make this distinction, which is misleading, and many of their partner distributors represent the solution as sterile.A simple google search of "mastisol sterile" identifies multiple distributor sites that directly represent the solution as sterile.In addition, the company represents the product as non-irritating despite publications and maude reports indicating otherwise, and the company claims that this class i device reduces clabsi.

• Brand Name: MASTISOL LIQUID ADHESIVE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ELOQUEST HEALTHCARE, INC. / FERNDALE LABORATORIES, INC.
• MDR Report Key: 18798416
• MDR Text Key: 336564772
• Report Number: MW5152060
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00496052348
• Device Catalogue Number: 00496052348
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White