ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 25, 2012 · Event occurred Mar 28, 2012
Report 2210968-2012-01236 · MDR key 2547622
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
XZW893
Lot number
CCK433
Product problems
- Needle, separation
Patient
Not reported
- Surgical procedure, additional
Narrative
Additional Manufacturer Narrative
CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BROW LIFT PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. WHEN THE SURGEON WAS SUTURING THE SUBCUTANEOUS TISSUE, THE NEEDLE PULLED OFF OF THE SUTURE. THE SURGEON WAS ABLE TO VISUALIZE THE NEEDLE AND MAKE A SMALL INCISION TO RETRIEVE THE NEEDLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
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.
Remedial action
- Other