NON-ABSORBABLE SURGICAL SUTURES
Received Jul 2, 2010 · Event occurred Jun 3, 2010
Report 2523835-2010-00055 · MDR key 1750475
Device
Generic name
Non-absorbable Suture
Manufacturer
Alcon Precision Device - Sinking SpringModel number
8065193101Catalog number
8065193101
Lot number
767779M
Product problems
- Dull, Blunt
Patient
67 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ADVERSE EVENT(S): "NO PT INJURY" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "NEEDLES IN THE PACK WERE BLUNT"(DULL). THE SURGEON REPORTED THAT UPON SUTURING THE OS LIMBUS TO THE CONJUNCTIVA, THE NEEDLE WOULD NOT PIERCE. BOTH NEEDLES IN THE PACK WERE BLUNT. THE DOCTOR USED ANOTHER SUTURE TO SUTURE THE WOUND. NO PT IMPACT WAS REPORTED. ADDITIONAL FOLLOW-UP INFO HAS BEEN REQUESTED.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).