FDA.reportPublic FDA data

MAUDE MDR 9666014

MDR report key
9666014
Report number
2210968-2020-00918
Event key
0
Event type
3
Date of event
2019-12-07
Date received
2020-02-04
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
1SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDRAGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASEDETHICON INC.LMG3013SP3013SPR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0401. R

Event Narratives#

N

Patient 1

PRODUCT COMPLAINT # (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. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? RELEVANT PATIENT HISTORY? ANY CONCURRENT USE OF OTHER PRODUCTS? PRODUCT CODE AND LOT #? WHAT WAS THE INTENDED USE OF THE SURGICEL? WHERE WAS THE SURGICEL USED (ON WHAT TISSUE)? HOW MUCH SURGICEL WAS USED DURING THE PROCEDURE? WAS THE SURGICEL PRODUCT LEFT IN PLACE? WAS THE EXCESS IRRIGATED AND REMOVED? WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? WERE CULTURES PERFORMED? IF YES, RESULTS? WHAT IS PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WAS THERE AN ALLEGED DEFICIENCY OF THE SURGICEL THAT CONTRIBUTED TO THE PATIENT?S POST-OPERATIVE INFECTION? POST-OPERATIVE HEMATOMA? WHAT IS THE PATIENT?S CURRENT STATUS? IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION? WHAT POST-OPERATIVE ANTIBIOTICS OR OTHER MEDICATIONS WERE PRESCRIBED FOR THE PATIENT?S TREATMENT? DO THE PATIENTS ROUTINELY RECEIVE PRE-OP OR POST-OP ANTIBIOTICS? HAS THE PRE OR POST OPERATIVE TREATMENT CHANGED AS A RESULT OF CHANGING FROM ARISTA TO SURGICEL?

D

Patient 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE SURGEON SAID HE SWITCHED BRANDS OF ABSORBABLE HEMOSTAT RECENTLY AND THE PATIENT DEVELOPED AN INFECTION. THE SURGEON USED THE ABSORBABLE HEMOSTAT PROPHYLACTICALLY FOR BLANKET COVERAGE AND DID NOT REMOVE THE EXCESS. HE ALSO USED AN AMNIOTIC TISSUE MEMBRANE ON THE VAGINAL CUFF AND SEPRAFILM WHEN CLOSING. THE PATIENT EXPERIENCED A FEVER AND HAD TO GO TO THE ER POST SURGERY. THE PATIENT DID NOT EXPERIENCE A POST-OP DEVICE MALFUNCTION. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THE PATIENT RECEIVED POST OP ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.