ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 39303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-01-03 for ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 39303 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[178231739] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[178231740] It was reported that the adhesive was too strong, and made the externals hard to remove. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-00054
MDR Report Key9544566
Report SourceCONSUMER,DISTRIBUTOR,OTHER
Date Received2020-01-03
Date of Report2020-01-06
Date Mfgr Received2020-01-04
Date Added to Maude2020-01-03
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 ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM
Generic NameMEC
Product CodeNNX
Date Received2020-01-03
Model Number39303
Catalog Number39303
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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