ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 13, 2012
Report 2210968-2012-02150 · MDR key 2614540
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
NI
Lot number
NI
Product problems
- Reaction
Patient
Not reported
- Surgical procedure
- Reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN APPENDECTOMY IN 1981 AND A HYSTERECTOMY IN 2001 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A STITCH SINUS IN 2011 AND (B)(6) OF 2012 PATIENT HAD REMOVAL OF THE SUTURE. THE PHYSICIAN BELIEVES IT TO BE SUTURE FROM THE APPENDECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Additional Manufacturer Narrative
CONCLUSION: THE RETURNED OPENED SAMPLE COMPRISED APPROXIMATELY 5CM OF GREEN BRAIDED SUTURE MATERIAL WITH A KNOT AND A LOOP AT ONE END. THE SUTURE HAD THE APPEARANCE OF ETHIBOND - POLYBUTYLATE COATED BRAIDED POLYESTER. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Remedial action
- Other