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

MAUDE Adverse Event Report: CAVN CAVN STETHOSCOPE STETHOSCOPE, MANUAL

  • 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
 

CAVN CAVN STETHOSCOPE STETHOSCOPE, MANUAL Back to Search Results
Model Number SC133
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 01/07/2020
Event Type  Injury  
Event Description
Bought cavn brand stethoscope from (b)(6), the products claim latex free on advertising picture. I used 2 weeks and it got my skin of neck latex allergy. In addition, the cavn stethoscope does not have fda device listing and mfr registration. I believe they market their products illegally and fail to meet fda requirements; because no lot number, mfr info, distributor info, and exp date on product packaging and product itself. Product listing linkage: (b)(6). Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAVN STETHOSCOPE
Type of DeviceSTETHOSCOPE, MANUAL
Manufacturer (Section D)
CAVN
MDR Report Key9581818
MDR Text Key174895488
Report NumberMW5092193
Device Sequence Number1
Product Code LDE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC133
Device Catalogue NumberNO CAT NUMBER
Device Lot NumberNO LOT NUMBER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/10/2020 Patient Sequence Number: 1
-
-