• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER STAINLESS STEEL BLADES BLADE 15 SHRP KNF BP SS TISS SURG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPEN SURGICAL BARD-PARKER STAINLESS STEEL BLADES BLADE 15 SHRP KNF BP SS TISS SURG Back to Search Results
Model Number 371215
Device Problems Material Discolored (1170); Structural Problem (2506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Event Description
Blade package was opened during pre-surgical set up when scrub tech noticed ragged cutting edge and discoloration of blade.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD-PARKER STAINLESS STEEL BLADES
Type of DeviceBLADE 15 SHRP KNF BP SS TISS SURG
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr.
caledonia MI 49316
Manufacturer (Section G)
ASPEN SURGICAL
6945 southbelt dr.
caledonia MI 49316
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, MO 65738
4176473205
MDR Report Key12094392
MDR Text Key263106337
Report Number3014527682-2021-00012
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 Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371215
Device Catalogue Number371215
Device Lot Number0240091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-