FDA.reportPublic FDA data

MAUDE MDR 8323290

MDR report key
8323290
Report number
2210968-2019-78796
Event key
0
Event type
3
Date of event
2018-12-21
Date received
2019-02-08
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, NONABSORBABLEETHICON INC.GAOSUTUREUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-0801. 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. 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. IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR OPERATIVE REPORT? DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? ADVERSE EVENT RELATED TO MESH REPORTED VIA MW # 2210968-2019-78797.

D

Patient 1

IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT HAD SURGERY TO PARTIALLY REMOVE MESH AND SUTURE. THE PATIENT REPORTED THEY WERE HAVING PAIN FROM MESH AND SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.