MalfunctionITX
SHEATHES3D
Received Aug 18, 2021 · Event occurred Jun 28, 2021
Report 12335804 · MDR key 12335804
Device
Generic name
Transducer, Ultrasonic, Diagnostic
Manufacturer
Sheathing Technologies, Inc.Model number
ADH-35-4Catalog number
ADH-35-4
Lot number
SJ20-50
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SHEATHING TECHNOLOGIES, INC. SHEATHES3D ULTRASOUND ADHESIVE PATCH DOES NOT HAVE ADHESIVE /GEL, THEREFORE DOES NOT ADHERE TO THE US PROBE COVER. UNABLE TO USE PRODUCT AS INTENDED.
Description of Event or Problem
SHEATHING TECHNOLOGIES, INC. SHEATHES3D ULTRASOUND ADHESIVE PATCH DOES NOT HAVE ADHESIVE /GEL, THEREFORE DOES NOT ADHERE TO THE US PROBE COVER. UNABLE TO USE PRODUCT AS INTENDED.