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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II EXACT 45DEG X 14MM; LAVAGE, JET
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SMITH & NEPHEW MEDICAL LTD. VERSAJET II EXACT 45DEG X 14MM; LAVAGE, JET Back to Search Results
Catalog Number 66800041
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Event Description
It was reported that before treatment too much water comes out of the handpiece with enough pressure to cut skin.The backup device was available, delay under 30 minutes reported.No harm nor injury reported to the patient or user.
 
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Brand Name
VERSAJET II EXACT 45DEG X 14MM
Type of Device
LAVAGE, JET
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK   HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
4407940038
MDR Report Key9516855
MDR Text Key174182175
Report Number8043484-2019-00946
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 company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/10/2020
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 Catalogue Number66800041
Device Lot Number50808824
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2019
Initial Date FDA Received12/24/2019
Supplement Dates Manufacturer Received12/08/2020
Supplement Dates FDA Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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