ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 13, 2012
Report 2210968-2012-02128 · MDR key 2614438
Device
Generic name
Suture, Non Absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
NI
Lot number
NI
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Scar Tissue
- Urinary Tract Infection
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC FLOOR LIFT PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE PATIENT HAS EXPERIENCED INABILITY TO HAVE A BOWEL MOVEMENT AND SEVERAL URINARY TRACT INFECTIONS. SHE STATES THAT SHE HAS HAD SEVERAL MEDICAL TESTS TO DETERMINE THE CAUSE OF THE REPORTED EVENTS. THERE IS CONCERN OVER SCAR TISSUE AND NERVE PROBLEMS.
Additional Manufacturer Narrative
(B)(4): INABILITY TO HAVE BOWEL MOVEMENT. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. (B)(6). THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2012-02127 AND 2210968-2012-02129. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Additional Manufacturer Narrative
(B)(4). IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS A VAGINAL VAULT SUSPENSION WITH A HIGH UTEROSACRAL LIGAMENT SUSPENSION THROUGH A POSTERIOR COLPOTOMY. THE PROCEDURE WAS MORE DIFFICULT THAN A TYPICAL PROCEDURE BECAUSE IT WAS PERFORMED TRANSVAGINALLY AND REQUIRED PRESERVATION OF THE UTERUS. THE PATIENT CONCOMITANTLY UNDERWENT AN ANTERIOR REPAIR WITH KELLY-KENNEDY PLACATION, A POSTERIOR REPAIR, CHEMODENERVATION AND A CYSTOSCOPY. ADDITIONAL INFORMATION WAS REQUESTED.
Remedial action
- Other