MAUDE Adverse Event Report: V. MUELLER / CAREFUSION 2200, INC V. MUELLER; FORCEPS, GENERAL PLASTIC SURGERY

Model Number SU2804

Device Problem Entrapment of Device (1212)

Patient Problems Laceration(s) (1946); Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Doctor noted on the post operative x-ray a metal fragment that was not part of the total joint.The surgical camp was found, and it was missing one of 3 teeth.The patient decided to undergo another surgery in order to have the metal fragment removed.

• Brand Name: V. MUELLER
• Type of Device: FORCEPS, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): V. MUELLER / CAREFUSION 2200, INC; 5 sunnen dr; saint louis MO 63143
• MDR Report Key: 14021260
• MDR Text Key: 288667196
• Report Number: 14021260
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022

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 Operator: Health Professional
• Device Model Number: SU2804
• Device Catalogue Number: SU2804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17155 DA
• Patient Sex: Female