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-PUERTO RICO FEMORAL CANAL BRUSH; LAVAGE, JET
  • 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-PUERTO RICO FEMORAL CANAL BRUSH; LAVAGE, JET Back to Search Results
Catalog Number 0210004000
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2015
Event Type  malfunction  
Event Description
It was reported that during a procedure some brushes from the device fell off inside the patient.No further information was available from the user facility.
 
Event Description
It was reported that during a procedure some brushes from the device fell off inside the patient.No further information was available from the user facility.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FEMORAL CANAL BRUSH
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5345197
MDR Text Key35096560
Report Number0001811755-2016-00012
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0210004000
Device Lot Number14310012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-