FDA Adverse Event Other Summary report: N

QUILL REF RA-1028-Q

MDR report key: 1603957 · Received February 8, 2010

Report

Report Number
MW5014729
Event Type
Other
Date Received
February 8, 2010
Manufacturer
ANGIOTECH
Product Code
GAK
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PT HAS HAD MULTIPLE SUTURE GRANULOMAS OF BOTH THE DEEP #2 SUTURE AND THE MORE SUPERFICIAL #2-0 SUTURE. THE SUTURE THAT WAS USED WAS QUILL PDO SUTURE MATERIAL. (MANUFACTURED BY ANGIOTECH) THIS HAS LEAD TO MULTIPLE (BI-WEEKLY) INTERACTIONS WITH SAID PT TO REMOVE NON-ABSORBED SUTURE MATERIAL AND DRAIN MULTIPLE STITCH GRANULOMAS OVER THE LAST 6-8 WEEKS. DATES OF USE: (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: SURGICAL CLOSURE OF DEFECT. THIS IS A CONTINUATION OF FORM COMPLETED BY DR (B) (6). (I AM THE PT ADDING TO THE REPORT). I TOO AM A HEALTH CARE PROFESSIONAL (REGISTERED NURSE). I HAVE EXPERIENCED UPON WOUNDS FROM THIS SUTURE SINCE THE END OF (B) (6) THRU PRESENT ((B) (6) 2010). UNABLE TO HEAL PROPERLY AND CAN PROVIDE PICTURES, TIMELINES OF CONTINUED COMPLICATIONS AND REMOVED PRODUCT TO DATE. PLEASE INVESTIGATE THIS PRODUCT AS I HAVE SPOKE TO TWO OTHER PLASTIC SURGEONS WHO HAVE TAKEN PTS BACK TO THE OPERATING ROOM TO REMOVE THIS SAME QUILL SUTURE USED FOR MY PROCEDURE. I TOO, HAVE HAD TWO PRIOR SURGERIES WITH INCISIONS IN EXCESS OF 12-16 CONSECUTIVE INCHES WITH NO WOUND COMPLICATIONS DUE TO UNABSORBED "ABSORBABLE" SUTURE. THIS SUTURE IS CAUSING WOUND HEALING PROBLEMS. PTS ARE SUFFERING WHILE PHYSICIANS REMOVE IT AND MANY TIMES DON'T REPORT IT. RISK MGMT DEPTS NEED TO BE ALERTED OF WOUND COMPLICATION WITH NO POSITIVE INFECTION IDENTIFIED. COMPLICATION COULD BE A RESULT OF "ABSORBABLE" SUTURE BEING USED THAT IS NOT FULLY ABSORBABLE. PTS ARE REJECTING PRODUCT AND WOUNDS ARE OPENING AS A RESULT. THIS PROBLEM NEEDS TO BE ADDRESSED. (B) (6)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 QUILL REF RA-1028-Q NONE GAK ANGIOTECH UNK

Patients

Seq Age Sex Outcome Treatment
1