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: COSMAN MEDICAL RF CANNULA
  • 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
 

COSMAN MEDICAL RF CANNULA Back to Search Results
Model Number RFK-C10520S-P
Device Problem No Apparent Adverse Event (3189)
Patient Problems Inflammation (1932); Rash (2033)
Event Date 05/05/2017
Event Type  Injury  
Event Description
A report was received that following a procedure, the patient experienced an allergic reaction at the location where the cannula was inserted.It is not known if any treatment was provided at this time.
 
Manufacturer Narrative
Additional information stated that no further information could be obtained regarding this event.
 
Event Description
A report was received that following a procedure, the patient experienced an allergic reaction at the location where the cannula was inserted.It is not known if any treatment was provided at this time.
 
Manufacturer Narrative
(b)(4), lot i757 rfk cannula 100mm, 5mm tip, 20g, sharp, curved 10/pk.The returned cannula exhibits normal device characteristics.Review of the device history/ packaging/ sterilization dhr revealed no anomalies.
 
Event Description
A report was received that following a procedure, the patient experienced an allergic reaction at the location where the cannula was inserted.It is not known if any treatment was provided at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RF CANNULA
Type of Device
CANNULA
Manufacturer (Section D)
COSMAN MEDICAL
22 terry ave
burlington MA 01803
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6592718
MDR Text Key76009474
Report Number3006630150-2017-01950
Device Sequence Number1
Product Code GXI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060799
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date02/03/2021
Device Model NumberRFK-C10520S-P
Device Lot NumberI757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-