ETHIBOND EXTRA & EXCEL POLYSTER SUTURE
Received Sep 17, 2009 · Event occurred Aug 14, 2009
Report 2210968-2009-01060 · MDR key 1478019
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
MX69G
Lot number
APB541
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Wound Dehiscence
- Surgical procedure
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT PRESENTED WITH A WOUND DEHISCENCE THREE DAYS FOLLOWING SURGERY. THE PT WAS RETURNED TO SURGERY FOR REPAIR. NO FURTHER INFO WAS PROVIDED.
Additional Manufacturer Narrative
DATE SENT TO THE FDA: 09/17/2009. WOUND DEHISCENCE OCCURRED - RESULT: REPRESENTATIVE SAMPLES OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE ETHICON REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM REQUIREMENTS. CONCLUSION: NO FAILURE DETECTED AND THE PRODUCT EXCEEDS TENSILE STRENGTH REQUIREMENTS.