Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC Back to Search Results
Catalog Number 5921034235
Medical Device Problem Codes Decrease in Pressure (1490); Pressure Problem (3012)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/18/2018
Type of Reportable Event Malfunction
Event or Problem Description
The tourniquet cuff lost inflation during a procedure.There was no delay, no medical intervention, and no adverse consequences.The procedure was completed successfully.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The tourniquet cuff lost inflation during a procedure.There was no delay, no medical intervention, and no adverse consequences.The procedure was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT
Common Device Name
TOURNIQUET, PNEUMATIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7757012
Report Number0001811755-2018-01569
Device Sequence Number1280312
Product Code KCY
UDI-Device Identifier37613154599470
UDI-Public37613154599470
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/01/2018
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
Operator of Device No Information
Device Catalogue Number5921034235
Device Lot Number60087127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Initial Date Received by Manufacturer 07/18/2018
Supplement Date Received by Manufacturer09/25/2018
Initial Report FDA Received Date08/07/2018
Supplement Report FDA Received Date10/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-