BARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10) 0086

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for BARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10) 0086 manufactured by Aspen Surgical Products, Inc..

Event Text Entries

[181771070] Dull bard-parker blade (no. 10) in package. Would not cut through muscle. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093344
MDR Report Key9763993
Date Received2020-02-26
Date of Report2020-02-24
Date of Event2020-02-21
Date Added to Maude2020-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10)
Generic NameBLADE, SURGICAL
Product CodeGES
Date Received2020-02-26
Catalog Number0086
Lot Number0200328
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, INC.
Manufacturer AddressCALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.