• 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. SUTURE UNKNOWN

  • 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. SUTURE UNKNOWN Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Conclusion: to date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that the patient underwent a dental surgical procedure on (b)(6) 2016 and unknown suture was used. During the procedure, when the suture package was opened and it was an attempt to grab the needle using a needle driver/holder, the needle fell off of the suture. The procedure was completed with another like suture. There were no patient consequences reported. No further information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSUTURE UNKNOWN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5668025
MDR Text Key46290440
Report Number2210968-2016-09116
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 04/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received04/29/2016
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

-
-