• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II EXACT 45DEG X 14MM; 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
 

SMITH & NEPHEW MEDICAL LTD. VERSAJET II EXACT 45DEG X 14MM; LAVAGE, JET Back to Search Results
Model Number 66800041
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 07/23/2017
Event Type  malfunction  
Event Description
It was reported at first, it comes out very well.After a certain period of use, it is sprayed like a sprayer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERSAJET II EXACT 45DEG X 14MM
Type of Device
LAVAGE, JET
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU32B N
UK  HU32BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
76. s meridan avenue
oklahoma city OK 73107
Manufacturer Contact
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key6803063
MDR Text Key83118380
Report Number8043484-2017-00206
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2017
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 Number66800041
Device Catalogue Number66800041
Device Lot Number50654451
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/24/2017
Initial Date FDA Received08/18/2017
Supplement Dates Manufacturer Received07/24/2017
Supplement Dates FDA Received12/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-