FDA.reportPublic FDA data

MAUDE MDR 9373849

MDR report key
9373849
Report number
2210968-2019-90305
Event key
0
Event type
3
Date of event
2019-01-01
Date received
2019-11-25
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
1SUTURE UNKNOWNSUTURE, NONABSORBABLEETHICON INC.GAOSUTUREUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-250

Event Narratives#

N

Patient 1

(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PRODUCT CODE AND LOT #? ANY PATIENT CONSEQUENCES AS A RESULT OF EVENT REPORT? WAS PROCEDURE COMPLETED SUCCESSFULLY? PLEASE CONFIRM THE SPECIFIC NUMBER OF PATIENT EVENTS ?

D

Patient 1

I WOULD LIKE TO REPORT TWO INCIDENCES WHERE A NEEDLE HAS BECOME COMPLETELY DETACHED FROM THE SUTURE MATERIAL. IN BOTH INSTANCES, ONE WHICH HAPPENED TODAY AND ALSO ONCE LAST WEEK, THE SUTURE HAD BEEN PASSED THROUGH THE TISSUE AND THEN BECAME DETACHED, LEAVING THE SUTURE MATERIAL IN THE TISSUE OF THE PATIENT AND THE NEEDLE SEPARATE IN THE NEEDLE HOLDER. OBVIOUSLY THIS IS VERY UNSATISFACTORY, AND FELT IT NEEDED TO BE REPORTED.