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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER 15 BLADE BLADE, SCALPEL

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ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER 15 BLADE BLADE, SCALPEL Back to Search Results
Catalog Number 371115
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
Scalpel blade tip, approx 2-3 mm broke deep in vertebral body during l4-l5 diskectomy. Scalpel blade used to scrape bony defects during decompression procedure. Tip appears to the right-side of the l4-l5 disc space. Fda safety report id # (b)(4).
 
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Brand NameBARD-PARKER 15 BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
caledonia MI 49316
MDR Report Key14075146
MDR Text Key289088483
Report NumberMW5108877
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 Administrator/Supervisor
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number371115
Device Lot Number0256657
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/08/2022 Patient Sequence Number: 1
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