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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME TC SWING-AWAY MODEL; CHAIR, ADJUSTABLE, MECHANICAL
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STRYKER MEDICAL-KALAMAZOO PRIME TC SWING-AWAY MODEL; CHAIR, ADJUSTABLE, MECHANICAL Back to Search Results
Model Number 1460-000-000
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.2 devices were not evaluated, as the issues were identified and resolved during troubleshooting calls between the customer and stryker technical support.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 3 malfunction events, where it was reported the devices experienced sharp metal edges.There was no patient involvement.
 
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Brand Name
PRIME TC SWING-AWAY MODEL
Type of Device
CHAIR, ADJUSTABLE, MECHANICAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
kaitlyn matheny
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key12234113
MDR Text Key264058980
Report Number0001831750-2021-01101
Device Sequence Number1
Product Code INN
UDI-Device Identifier07613327282665
UDI-Public07613327282665
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1460-000-000
Device Catalogue Number1460000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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