ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 16, 2011
Report 2210968-2011-00784 · MDR key 2131269
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon IncModel number
NACatalog number
4PA6343YH
Lot number
CM8HLWM0
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). CONCLUSION: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE NEEDLES WERE INSPECTED AND TESTED FOR KNOT PULL AND KNOT GLIDING STRENGTH AND THE PRODUCT MET REQUIREMENTS.
Additional Manufacturer Narrative
(B)(4). KNOTS UNTYING. 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. 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 THE KNOTS DO NOT HOLD AND UNTYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Remedial action
- Other