MAUDE Adverse Event Report: CONMED LINVATEC / LINVATEC CORPORATION D/B/A DIGIT TRAP FINGER GRASPING DEVICE; APPARATUS, TRACTION, NON-POWERED

Model Number 9906

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

Patient Problem Laceration(s) (1946)

Event Date 06/22/2021

Event Type  malfunction  

Event Description

Product caused laceration to digit.

• Brand Name: DIGIT TRAP FINGER GRASPING DEVICE
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): CONMED LINVATEC / LINVATEC CORPORATION D/B/A; 1131 concept blvd; largo FL 33773
• MDR Report Key: 12066661
• MDR Text Key: 258732870
• Report Number: MW5102137
• Device Sequence Number: 1
• Product Code: HST
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9906
• Device Catalogue Number: 9906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR