• 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 PRODUCTS, INC BARD-PARKER SAFETY SCALPEL BLADE, SCALPEL

  • 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 PRODUCTS, INC BARD-PARKER SAFETY SCALPEL BLADE, SCALPEL Back to Search Results
Model Number 0086
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/24/2020
Event Type  malfunction  
Event Description
15 blade broke off and tip remained inside patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD-PARKER SAFETY SCALPEL
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key10114027
MDR Text Key193628054
Report Number10114027
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 Risk Manager
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0086
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2020
Event Location Hospital
Date Report to Manufacturer06/03/2020
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?
Type of Device Usage

Patient Treatment Data
Date Received: 06/03/2020 Patient Sequence Number: 1
-
-