FDA.reportPublic FDA data

MAUDE MDR 6166130

MDR report key
6166130
Report number
2210968-2016-15411
Event key
0
Event type
3
Date of event
2016-11-23
Date received
2016-12-12
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
KRYSTINA LAGUNA
Address
ROUTE 22 WESTP O BOX 151 SOMERVILLE NJ 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUTURE UNKNOWNETHICON INC.GAOUNKUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-120

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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING OR AFTER ITS USE IN THE PATIENT: DURING ITS USE. DID ANY PIECE OF THE NEEDLE FALL INSIDE OF THE PATIENT? IF SO, WAS THE NEEDLE PIECE REMOVED AND HOW: NO. WHEN DID THE NEEDLE PULL OFF (WHILE IN THE PACKAGE / DURING DISPENSING / DURING PREPARATION / DURING USE): DURING ITS USE. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE DEVICE USED: NO. ARE THERE ANY SAMPLES AVAILABLE TO BE RETURNED FOR EVALUATION: NO.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT GASTROPLASTY PROCEDURE ON (B)(6) 2016 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF FROM THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.