InjuryGAS
SURGIPRO II 6/0 30 BLUE CVF-11 D/A
Received Mar 2, 2012
Report 2647580-2012-00161 · MDR key 2480156
Device
Generic name
Nonabsorbable Suture Product
Manufacturer
Ussc Puerto RicoCatalog number
VPF706X
Lot number
T1E0099B
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PROCEDURE TYPE: COSMETIC. ACCORDING TO THE REPORTER: THE NEEDLE BROKE AFTER 1-3 TUCKS DURING LID PLASTIC SURGERY WITHOUT USING MUCH FORCE. FRAGMENTS FELL ONTO THE PATIENT'S OPEN EYE BUT IT WAS POSSIBLE TO RETRIEVE THEM. SURGERY WAS DELAYED FOR MORE THAN 30 MINUTES. NO ADDITIONAL BLOOD LOSS. NO LOSS OR IRREVERSIBLE DAMAGE TO VASCULAR TISSUE.
Additional Manufacturer Narrative
(B)(4).