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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU BETTER ELECTRIC COMPANY BLADE, SURGICAL CLIPPER, STANDARD PREP
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JIANGSU BETTER ELECTRIC COMPANY BLADE, SURGICAL CLIPPER, STANDARD PREP Back to Search Results
Model Number CAH4406D
Device Problem Sharp/jagged/rough/etched/scratched (2594)
Patient Problem Nicks, cuts or tears of dura or other tissues by device (1417)
Event Date 04/08/2014
Event Type  malfunction  
Event Description
During the prep for a penile implant, the nurse was shaving the patient's scrotum and the blade removed the patients skin.Apparently the cut was about an inch wide by 3 inches long.
 
Manufacturer Narrative
No samples were received for evaluation; therefore we are unable to determine the cause for the issue reported.A review of the device history record could not be performed as a lot number was not reported.We will continue to monitor for any similar reports.
 
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Brand Name
BLADE, SURGICAL CLIPPER, STANDARD PREP
Type of Device
BLADE, SURGICAL CLIPPER, STANDARD PREP
Manufacturer (Section D)
JIANGSU BETTER ELECTRIC COMPANY
11 hui hai rd, bin hai zone
qi dong, jiang su 2262 00
CH  226200
Manufacturer Contact
michele donatich
1500 waukegan road
waukegan, IL 60085
8478876412
MDR Report Key3870410
MDR Text Key4593916
Report Number1423537-2014-00019
Device Sequence Number1
Product Code LWK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/23/2014,06/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberCAH4406D
Device Catalogue NumberCAH4406D
Device Lot NumberNO LOT GIVEN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date05/16/2014
Event Location Hospital
Date Report to Manufacturer05/23/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
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