PRECEPT 66-2411

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-09-26 for PRECEPT 66-2411 manufactured by Guangzhou Fortunique Limited.

Event Text Entries

[15614876] Nurse(s) experienced irritation due to the elastic band. Prior primary skin irritation studies reflects the elastic to be non-irritatant. No samples or lot numbers were available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number59995-1997-00003
MDR Report Key124286
Report Source07
Date Received1997-09-26
Date of Report1997-09-22
Date of Event1996-11-14
Date Mfgr Received1996-11-14
Date Added to Maude1997-10-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRECEPT
Generic NameBOUFFANT CAP
Product CodeFYF
Date Received1997-09-26
Model Number66-2411
Catalog Number66-2411
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key121689
ManufacturerGUANGZHOU FORTUNIQUE LIMITED
Manufacturer Address3/F B. NO. 18 TIAHEGAN XIANLIE ZHOUNG ROAD GUANGZHOU CH 510070
Baseline Brand NamePRECEPT
Baseline Generic NameBOUFFANT CAP
Baseline Model No66-2411
Baseline Catalog No66-2411
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-09-26

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