• 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 BIOCLUSIVE 20X30CM STERILE FILM DRESSING

  • 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 BIOCLUSIVE 20X30CM STERILE FILM DRESSING Back to Search Results
Model Number BIP2030
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2017
Event Type  malfunction  
Event Description
Customer rejected 90 pieces due to finding a narrow seal down one side of the product.
 
Event Description
Customer rejected 90 pieces due to finding a narrow seal down one side of the product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOCLUSIVE 20X30CM STERILE
Type of DeviceFILM DRESSING
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key7017691
MDR Text Key120299888
Report Number1836161-2017-00117
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBIP2030
Device Lot Number138388
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-