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

MAUDE Adverse Event Report: EQUIDYNE SYSTEMS, INC. INJEX 30 0.3 AMPULE HOLDS THE SINSULIN AND IS THE INJECTION PART OF THE INJECTOR

  • 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
 

EQUIDYNE SYSTEMS, INC. INJEX 30 0.3 AMPULE HOLDS THE SINSULIN AND IS THE INJECTION PART OF THE INJECTOR Back to Search Results
Model Number INJEX 30 0.3 AMPULE
Event Date 08/19/2005
Event Type  Other  
Event Description

While injecting insulin with the injex-30 injector the ampule shattered, this is number 4.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINJEX 30 0.3 AMPULE
Type of DeviceHOLDS THE SINSULIN AND IS THE INJECTION PART OF THE INJECTOR
Manufacturer (Section D)
EQUIDYNE SYSTEMS, INC.
san diego CA *
MDR Report Key751202
Report NumberMW1036412
Device Sequence Number1
Product CodeKZE
Report Source Voluntary
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 08/19/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2005
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberINJEX 30 0.3 AMPULE
Device Catalogue NumberP/N 100100
Device LOT Number3481A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Unknown
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/19/2005 Patient Sequence Number: 1
-
-