FDA.reportPublic FDA data

MAUDE MDR 8540151

MDR report key
8540151
Report number
2210968-2019-80612
Event key
0
Event type
3
Date received
2019-04-23
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
DARLENE KYLE
Address
P.O. BOX 151, ROUTE 22 WEST 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 UNKNOWNSUTURE, ABSORBABLEETHICON INC.GAKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-2301. R

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 TIP OF THE NEEDLE BREAK OFF DURING THE INDEX NEURO PROCEDURE? OR DID THE TIP OF THE NEEDLE BREAK OFF WHEN THE PATIENT WAS BROUGHT BACK FOR IND (INCISION AND DRAINAGE PROCEDURE)? -NEEDLE BROKE OFF DURING THE ORIGINAL NEURO PROCEDURE. IF THE NEEDLE TIP BROKE DURING THE IND PROCEDURE, WAS THE NEEDLE TIP REMOVED DURING THE IND PROCEDURE? TIP WAS FOUND DURING I&D PROCEDURE AND REMOVED. DATE OF THE IND PROCEDURE UNKNOWN. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE - UNKNOWN AND NAME OF INDEX SURGICAL PROCEDURE - UNKNOWN. WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? UNKNOWN. WHERE WAS THE NEEDLE GRASPED DURING USE? UNKNOWN. PRODUCT CODE AND LOT # - UNKNOWN. IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION- NO. HOSPITAL DISPOSED OF PRODUCT. WHAT IS PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT- UNKNOWN. WHAT IS THE PATIENT CURRENT STATUS? UNKNOWN. POST OP AFTER THE INCISION AND DRAINAGE PROCEDURE THE PATIENT WAS BROUGHT BACK BECAUSE OF AN INFECTION. THE SURGEON WAS NOT SURE OF THE CAUSE.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN NEUROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF. WHEN THE PATIENT WAS BROUGHT BACK FOR IND (INCISION AND DRAINAGE PROCEDURE) ON AN UNKNOWN DATE, THE TIP FLOATED TO THE TOP WHEN THEY IRRIGATED AND REMOVED THE TIP. THE PATIENT?S CURRENT STATUS IS UNKNOWN. POST-OP AFTER THE INCISION AND DRAINAGE PROCEDURE THE PATIENT WAS BROUGHT BACK BECAUSE OF AN INFECTION. THE SURGEON WAS NOT SURE OF THE CAUSE. NO ADDITIONAL INFORMATION WAS PROVIDED.