InjuryGAS
ETHIBOND
Received Jul 10, 2013
Report 2210968-2013-12796 · MDR key 3217669
Device
Generic name
Suture Non Absorbable
Manufacturer
Ethicon Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
10 YR
- Granuloma
- Unspecified Infection
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TIBIALIS ANTERIOR TENDON TRANSFER ON (B)(6) 2012 AND SUTURE WAS USED. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR AN INCISION AND DRAINAGE AND EXISION OF BILATERAL PLANTAR SUTURE GRANULOMAS. THE PATIENT ALSO CULTURED FOR STAPH AUREUS.
Additional Manufacturer Narrative
(B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.