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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RYCOR RYCOR HAND TABLE

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RYCOR RYCOR HAND TABLE Back to Search Results
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Event Description
Hand table purchased (b)(6) 2021. In march the mounting bracket broke on one side replacement part was sent in at no charge. On (b)(6) the bracket broke again this time both sides.
 
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Type of DeviceRYCOR HAND TABLE
Manufacturer (Section D)
RYCOR
2053 atwater dr.
north port FL 34288
MDR Report Key12266780
MDR Text Key264915786
Report Number12266780
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2021
Event Location Hospital
Date Report to Manufacturer08/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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