Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
  • 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
 

COVIDIEN LP LLC NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED Back to Search Results
Model Number HP0204E
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the patches were totally dry and they were breaking down.There was no patient involvement.
 
Additional Manufacturer Narrative
Report sent in error.Product is neither marketed nor is a similar product that is marketed in the us.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERISET
Common Device Name
AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mc dermott rd
north haven CT 06473
MDR Report Key7048974
Report Number1219930-2017-08983
Device Sequence Number11077835
Product Code LMG
UDI-Device Identifier10884521082533
UDI-Public10884521082533
Combination Product (Y/N)N
Initial Reporter CountryFI
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/03/2018
Device Model NumberHP0204E
Device Catalogue NumberHP0204E
Device Lot NumberN7G0040X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/09/2017
Supplement Date Received by Manufacturer01/12/2018
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date02/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-