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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER CARBON RIB-BACK BLADE BLADE, SCALPEL

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ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER CARBON RIB-BACK BLADE BLADE, SCALPEL Back to Search Results
Model Number 371110
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/07/2018
Event Type  malfunction  
Event Description
Blade broke off inside patient wound during procedure.
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key7788512
MDR Text Key117283587
Report Number7788512
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110
Device Catalogue Number0086
Device Lot Number0155124
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/09/2018
Event Location Hospital
Date Report to Manufacturer08/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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