• 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, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE BARD PARKER BLADE

  • 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, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE BARD PARKER BLADE Back to Search Results
Model Number 371110
Device Problems Hole In Material (1293); Device Packaging Compromised (2916)
Patient Problem No Information (3190)
Event Date 04/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported on (b)(4) that the sterility was compromised along with the seal integrity. There are pin holes in the packaging.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
Type of DeviceBARD PARKER BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer Contact
bradley liske
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6568760
MDR Text Key75409349
Report Number1836161-2017-00046
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2017
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

-
-