FDA.reportPublic FDA data

MAUDE MDR 9601286

MDR report key
9601286
Report number
2210968-2020-00456
Event key
0
Event type
3
Date received
2020-01-17
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
KARA DITTY-BOVARD
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
10 ENDOLOOP LIG W/PDS IICANNULA, SURGICAL, GENERAL AND PLASTIC SURGERYETHICON INC.GEAEZ10GY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-170

Event Narratives#

N

Patient 1

(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON BROKE OFF THE TIP OF THE CANULA AT THE BREAK POINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.