FDA.reportPublic FDA data

MAUDE MDR 6999166

MDR report key
6999166
Report number
8030965-2017-15912
Event key
0
Event type
3
Date of event
2017-10-11
Date received
2017-11-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL COTE
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DOUBLEAIRHOSE L5M F/SYST SYNTHESINSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENTSYNTHES OBERDORFHSZ519.530N/AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-030

Event Narratives#

N

Patient 1

(B)(4). (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS MEDWATCH IS BEING RESUBMITTED DUE TO OUTAGE IN FDA'S ELECTRONIC SUBMISSION GATEWAY (ESG) UPON INITIAL SUBMISSION.

D

Patient 1

IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE DOUBLE AIR HOSE DEVICE WAS PHYSICALLY DAMAGED. IT WAS REPORTED THAT THE EVENT OCCURRED BEFORE USE ON A PATIENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.