ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Apr 15, 2013
Report 2210968-2013-03895 · MDR key 3058035
Device
Generic name
Suture, Non Absorbable
Manufacturer
Ethicon, IncModel number
NACatalog number
EH7909H
Lot number
EM2CGMN0
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Surgical procedure
- Post Operative Wound Infection
Narrative
Additional Manufacturer Narrative
(B)(4). 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-03896. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT FUNNEL BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED AS FIXATION FOR THE IMPLANT. POST OPERATIVELY THE PATIENT DEVELOPED A MASSIVE WOUND INFECTION WHICH RESULTED IN ANOTHER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
(B)(4): REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. PACKAGING INTEGRITY TESTING MET THE REQUIREMENTS.
Remedial action
- Other