ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Dec 28, 2012
Report 2210968-2012-08486 · MDR key 2889103
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
NI
Lot number
NI
Product problems
- Reaction
Patient
Not reported
- Inflammation
- Impaired Healing
- Drainage
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REOPERATION FOR AN IMPLANTATION OF AN AUTOMATED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR ON (B)(6) 2012 AND SUTURE WAS USED. THE AUTOMATED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS IMPLANTED THIS TIME FROM THE RIGHT SIDE OF THE PATIENT. THE PATIENT DEVELOPED DRAINAGE, REDNESS, AND POOR WOUND HEALING AT THE INCISION SITE. THE SURGEON PLANS TO REMOVE THE SUTURE AND REPLACE WITH A DIFFERENT SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional 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. THIS IS ONE OF SIX MEDWATCHES BEING SUBMITTED. PLEASE SEE MEDWATCHES 2210968-2012-08482 THROUGH 2210968-2012-08487. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Remedial action
- Other