FDA.reportPublic FDA data

MAUDE MDR 8182168

MDR report key
8182168
Report number
3003639970-2018-00799
Event key
0
Event type
3
Date received
2018-12-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. NICOLE BROYLES
Address
615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
Phone
314-314-3145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MONOMAX VIOLET 1 (4) 200CM HR48 LOOP(M)SYNTHETIC ABSORBABLE MONOFILARB BRAUN SURGICAL SANWJB0041325B0041325117411N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-190

Event Narratives#

N

Patient 1

(B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "THE SURGEON WAS PERFORMING A HYSTERECTOMY ON A PATIENT WHO HAS HAD 3 MULTIPAROUS AND HAS CA GRADE 3. DURING THE PROCEDURE WHILE PERFORMING THE SECOND KNOTTING THE SUTURE BROKE, CAUSING A DELAY IN SURGERY WHEN THE SURGEON HAD TO COMPLETE THE SURGERY WITH ANOTHER SUTURE." ADDITIONAL PATIENT INFORMATION AND VERIFY DELAY TIME OF SURGERY HAS BEEN REQUESTED. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.