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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PUERTO RICO CORP. BARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL SCALPEL, ONE-PIECE

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ASPEN SURGICAL PUERTO RICO CORP. BARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL SCALPEL, ONE-PIECE Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2018
Event Type  malfunction  
Event Description
During an emergent cricothyrotomy a #11 bard-parker protected disposable scalpel tip broke off. The scalpel tip was removed from the patient's neck in the operating room. The blade was not tagged or saved after the event.
 
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Brand NameBARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL
Type of DeviceSCALPEL, ONE-PIECE
Manufacturer (Section D)
ASPEN SURGICAL PUERTO RICO CORP.
MDR Report Key7533802
MDR Text Key109103463
Report NumberMW5077361
Device Sequence Number0
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
Type of Report Initial
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

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