ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 30, 2011 · Event occurred May 24, 2011
Report 2210968-2011-00867 · MDR key 2146665
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon IncModel number
NACatalog number
EH6445H
Lot number
NI
Product problems
- Reaction
Patient
Not reported
- Pain
- Surgical procedure
- Impaired Healing
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE AND SUTURE WAS USED. APPROXIMATELY SIX MONTHS AFTER THE PROCEDURE, THE SUTURE CAUSED PAIN AND IMPAIRED WOUND HEALING. THE PATIENT UNDERWENT REOPERATION. THE WOUND WAS REOPENED AND THE SUTURE WAS REMOVED.
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
(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT THE INITIAL PROCEDURE ON (B)(6) 2010 TO REMOVE VARICOSE VEINS FROM THE THIGH AND SUTURE WAS USED.
Remedial action
- Other