• 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. SURGICAL GUT SUTURE - CHROMIC; SUTURE, ABSORBABLE, NATURAL

  • 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. SURGICAL GUT SUTURE - CHROMIC; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Catalog Number 724G
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Representative samples were returned for evaluation.Visual and functional inspections for ductility were performed and the samples met the requirements.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported by a veterinarian that an animal underwent an unknown procedure on (b)(6) 2015 and suture was used.During the procedure, the needle bent after a few passes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURGICAL GUT SUTURE - CHROMIC
Type of Device
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-JUAREZ
avenida de las torres 7125, co
l salvacar
ciudad juarez 32604
MX   32604
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5311786
MDR Text Key33907836
Report Number2210968-2015-20873
Device Sequence Number1
Product Code GAL
Combination Product (y/n)N
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 10/20/2015
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
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Catalogue Number724G
Device Lot NumberJDM739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/16/2015
Initial Date FDA Received12/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-