MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY; MOTOR, SURGICAL INSTRUMENT

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

Patient Problem Abrasion (1689)

Event Date 04/10/2019

Event Type  malfunction  

Event Description

When using bd clippers abrasions noted to left leg/groin.

• Type of Device: MOTOR, SURGICAL INSTRUMENT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8682785
• MDR Text Key: 147472458
• Report Number: 8682785
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2019
• Date Report to Manufacturer: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33215 DA