PERINEAL PAD SUPINE 72200634

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-23 for PERINEAL PAD SUPINE 72200634 manufactured by Smith & Nephew, Inc..

Event Text Entries

[90634103] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[90634104] It was reported that the patient complained of perineal bruising following a hip arthroscopy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003604053-2017-00314
MDR Report Key6970308
Date Received2017-10-23
Date of Report2018-11-15
Date of Event2017-05-18
Date Mfgr Received2018-11-15
Date Added to Maude2017-10-23
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 ContactJIM GONZALES
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street150 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePERINEAL PAD SUPINE
Generic NameCOMPONENT, TRACTION, NON-INVASIVE
Product CodeKQZ
Date Received2017-10-23
Catalog Number72200634
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-23

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