InjuryGAS
ETHIBOND
Received Jul 10, 2013
Report 2210968-2013-12731 · MDR key 3217723
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
8 YR
- Abscess
- Unspecified Infection
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE DISARTICULATION ON (B)(6) 2013 AND SUTURE WAS USED. THE PATIENT EXPERIENCED AN INFECTION AND SUTURE ABSCESS. THE PATIENT UNDEWENT AN INCISION AND DRAINAGE PROCEDURE ON (B)(6) 2013. AT THAT TIME, A DEEP CULTURE WAS DONE. THE CULTURE WAS POSITIVE FOR BACTEROIDES/PREVOTELLA SPECIES.
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.