FDA.reportPublic FDA data

MAUDE MDR 7117848

MDR report key
7117848
Report number
1417592-2017-00080
Event key
0
Event type
3
Date of event
2017-10-19
Date received
2017-12-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KAREN TRUTSCH
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SCALPEL,SAFETY,SS,DISPOSABLE,STERILEMEDLINE INDUSTRIES INC.GDXMDS15310R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-1401. O

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LIPOMA REMOVAL FOR A RECURRENT 11 CM LIPOMA ON HIS BACK. REPORTEDLY, DURING THE PATIENTS PROCEDURE THE BLADE BROKE OFF INSIDE OF THE PATIENT AND THE SURGEON COULD NOT REMOVE THE BLADE. ACCORDING TO THE FACILITY THE BLADE REMOVAL HAD TO BE DONE UNDER FLUOROSCOPY WHICH WAS NOT AVAILABLE AT THE SITE. THE PATIENT WAS SCHEDULED FOR FOLLOW UP TO HAVE THE BLADE REMOVED WITH ANOTHER CLINICIAN AT A DIFFERENT SITE AND THE PATIENT DID NOT FOLLOW UP. (B)(6) STATED THAT ACCORDING TO THE PATIENT'S MEDICAL RECORD THE BLADE DOES NOT APPEAR TO HAVE BEEN REMOVED AS OF THIS DATE. THE PATIENT DID RETURN TO THE SURGEON TO FOLLOW UP AND HAVE THE DRAIN AND SUTURES REMOVED AND THE SURGICAL SITE HEALED WITHOUT INCIDENT. NO ADDITIONAL DETAILS ARE AVAILABLE. A SAMPLE HAS NOT YET BEEN RETURNED FOR EVALUATION HOWEVER, DUE TO THE REPORTED INCIDENT, AND IN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED A BLADE BROKE IN A SURGICAL SITE.