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: ETHICON INC. MERSILENE POLYESTER FIBER SUTURE; SUTURE NON ABSORBABLE
  • 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
 

ETHICON INC. MERSILENE POLYESTER FIBER SUTURE; SUTURE NON ABSORBABLE Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Nerve Damage (1979); Surgical procedure (2357)
Event Type  Injury  
Event Description
It was reported by the patient that she underwent a procedure on and unknown date and suture was used.She stated that post operatively she developed nerve damage causing facial drooping.The patient underwent an open head and neck re-exploration, in which the surgeon removed the suture previously implanted.No further information is available at this time.
 
Manufacturer Narrative
(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MERSILENE POLYESTER FIBER SUTURE
Type of Device
SUTURE NON ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key3670662
MDR Text Key15103559
Report Number2210968-2014-02030
Device Sequence Number1
Product Code GAS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/13/2014
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
Patient Sequence Number1
-
-