ACTIVECARE +SFT SYSTEM WARNING: A502B000101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-12-30 for ACTIVECARE +SFT SYSTEM WARNING: A502B000101 manufactured by Zimmer Surgical, Inc..

Event Text Entries

[173252075] This event is recorded by zimmer biomet under (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet. Once the product is returned and the investigation is complete, a follow up/final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[173252076] It was reported that the patient stated that she only wore the device for two days. The patient's skin was fragile, and the device was ripping open her skin. The patient was told by pt to stop using the device. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001526350-2019-01202
MDR Report Key9530276
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-12-30
Date of Report2020-03-31
Date of Event2019-11-22
Date Mfgr Received2020-03-30
Device Manufacturer Date2018-05-02
Date Added to Maude2019-12-30
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER SURGICAL, INC.
Manufacturer Street200 WEST OHIO AVENUE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal Code44622
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameACTIVECARE +SFT SYSTEM WARNING:
Generic NameSLEEVE, LIMB, COMPRESSIBLE
Product CodeJOW
Date Received2019-12-30
Catalog NumberA502B000101
Lot Number63985102
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-12-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.