AMS SLING SYSTEM UNK-P-SLING-MENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for AMS SLING SYSTEM UNK-P-SLING-MENS manufactured by Boston Scientific Corporation.

Event Text Entries

[185914272] 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.
Patient Sequence No: 1, Text Type: N, H10


[185914273] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01772
MDR Report Key9908136
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2000-01-01
Date Mfgr Received2020-03-15
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALYSON HARRIS
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone4089353452
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal Code55343
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS SLING SYSTEM
Generic NameMESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Product CodeOTM
Date Received2020-03-31
Model NumberUNK-P-SLING-MENS
Catalog NumberUNK-P-SLING-MENS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address10700 BREN ROAD W MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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