ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Dec 28, 2012
Report 2210968-2012-08482 · MDR key 2888861
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 AN IMPLANTATION OF AN AUTOMATED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR ON (B)(6) 2012 AND SUTURE WAS USED. THE AUTOMATED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS IMPLANTED FROM THE LEFT SIDE OF THE PATIENT. THE PATIENT DEVELOPED DRAINAGE, REDNESS, AND POOR WOUND HEALING AT THE INCISION SITE. THE AUTOMATED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS REMOVED ON (B)(6) 2012 AND CULTURED. ALL CULTURES WERE NEGATIVE. THE PATIENT REQUIRED A REOPERATION TO IMPLANT THE AUTOMATED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: 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