ETHIBOND
Received Jul 10, 2013
Report 2210968-2013-12727 · MDR key 3216552
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
9 YR
- Unspecified Infection
- Surgical procedure
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ACHILLES TENDON LENGTHENING PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. THE PATIENT DEVELOPED A POSSIBLE INFECTION AND WAS RETURNED TO SURGERY ON (B)(6) 2013 FOR AN INCISION AND DRAINAGE. A DEEP CULTURE WAS TAKEN. THE CULTURE WAS NEGATIVE, HOWEVER, THE PATIENT HAD ALREADY BEEN TREATED WITH ANTIBIOTICS.
Additional Manufacturer Narrative
(B)(4) - INFECTION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.