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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PUERTO RICO CORP. BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE BLADE, SCALPEL

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ASPEN SURGICAL PUERTO RICO CORP. BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE BLADE, SCALPEL Back to Search Results
Model Number REF 373911
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
The safety blade that was opened for the procedure did not function properly - the protection over the blade would not slide open. A new blade was opened and the surgery was completed without incident. Fda safety report id# (b)(4).
 
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Brand NameBARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PUERTO RICO CORP.
MDR Report Key13118232
MDR Text Key283140404
Report NumberMW5106369
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 373911
Device Lot Number0230370
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

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