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U.S. Department of Health and Human Services

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

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V. MUELLER / CAREFUSION 2200, INC V. MUELLER; FORCEPS, GENERAL PLASTIC SURGERY Back to Search Results
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.
 
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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 Key14021260
MDR Text Key288667196
Report Number14021260
Device Sequence Number1
Product Code GEN
Combination Product (y/n)N
Number of Events Reported1
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 NumberSU2804
Device Catalogue NumberSU2804
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2022
Event Location Hospital
Date Report to Manufacturer04/06/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17155 DA
Patient SexFemale
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