InjuryGAS
TICRON # 5 BLUE 4X30 DT-20 / KV40
Received Dec 3, 2009 · Event occurred Oct 14, 2009
Report 9612501-2009-00078 · MDR key 1552163
Device
Generic name
Nonabsorbable Suture Product
Manufacturer
Santo Domingo - UssCatalog number
8886281889
Lot number
D7M351
Product problems
- Material Rupture
Patient
58 YR
- Fistula
Narrative
Description of Event or Problem
PROCEDURE: LUNG TRANSPLANT. ACCORDING TO THE REPORTER: ONE MONTH AFTER THE SURGICAL PROCEDURE, IT WAS NOTICED BY X-RAY RIB REMOTENESS. A FISTULA HAD OCCURRED BETWEEN THE RIBS. AFTER OPENING THE PATIENT, IT WAS NOTICED THAT THE SUTURE HAD BREACHED (RUPTURED AT 4 POINTS).
Additional Manufacturer Narrative
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