FDA.reportPublic FDA data

MAUDE MDR 3217669

MDR report key
3217669
Report number
2210968-2013-12796
Event key
0
Event type
3
Date received
2013-07-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KATHY RICE
Address
4545 CREEK RD CINCINNATI OH 45242 US
Phone
513-513-5133
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHIBONDSUTURE NON ABSORBABLEETHICON INC.GASUNKUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-1001. R

Event Narratives#

D

Patient 1

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.

N

Patient 1

(B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.