MAUDE Adverse Event Report: SHEATHING TECHNOLOGIES, INC. SHEATHES3D; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number ADH-35-4

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

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.

Event Description

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.

• Brand Name: SHEATHES3D
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): SHEATHING TECHNOLOGIES, INC.; 675 jarvis dr; 675 jarvis dr; morgan hill CA 95037
• MDR Report Key: 12335804
• MDR Text Key: 267046238
• Report Number: 12335804
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 10842418102085
• UDI-Public: (01)10842418102085
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADH-35-4
• Device Catalogue Number: ADH-35-4
• Device Lot Number: SJ20-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Date Report to Manufacturer: 08/18/2021
• Patient Sequence Number: 1