ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jul 25, 2011
Report 2210968-2011-00945 · MDR key 2175372
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Unspecified Infection
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
Narrative
Additional Manufacturer Narrative
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED BY A PATIENT THAT SHE HAD A PARTIAL HYSTERECTOMY ON (B)(6) 2009 AND SUTURE WAS USED. IMMEDIATELY AFTER THE SURGERY, THE PATIENT HAD AN INFECTION, PURULENT DISCHARGE AND BLEEDING FROM THE VAGINA AND BURNING. THE PATIENT HAD PAIN AND BLEEDING WITH INTERCOURSE AND LOSS OF SENSATION. THE PATIENT SAW ANOTHER SURGEON AND HAD A SECOND SURGERY DUE TO TEARING IN THE VAGINAL CUFF. A REVISION OF THE CUFF AND REMOVAL OF THE SUTURE WAS PERFORMED (B)(6) AGO.
Remedial action
- Other