FDA.reportPublic FDA data

MAUDE MDR 9908136

MDR report key
9908136
Report number
2183959-2020-01772
Event key
0
Event type
3
Date of event
2000-01-01
Date received
2020-03-31
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
ALYSON HARRIS
Address
10700 BREN ROAD W MINNETONKA MN 55343 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMS SLING SYSTEMMESH SURGICAL FOR STRESS URINARY INCONTINENCE MALEBOSTON SCIENTIFIC CORPORATIONOTMUNK-P-SLING-MENSUNK-P-SLING-MENSR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

N

Patient 1

AS THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT, THE REPORTED ALLEGATION COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED.

D

Patient 1

IT WAS REPORTED THAT RESEARCH AN DEVELOPMENT ENGINEER WAS OBSERVING MARKET RESEARCH/ VOICE OF CUSTOMER (VOC) WHEN A PATIENT INDICATED THAT HE HAD A SLING IMPLANTED IN 2000 AND DURING THE PROCEDURE HIS NERVES WERE CRUSHED AND IT CAUSED SIGNIFICANT PAIN. IT IS UNKNOWN IF THIS WAS A BSC SLING.