TOWEL OR 17X24IN BLUE STERILE 4/PK 28700-004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-22 for TOWEL OR 17X24IN BLUE STERILE 4/PK 28700-004 manufactured by Jianerkang Medical Dressing Co, Ltd.

MAUDE Entry Details

Report Number1423537-2019-00334
MDR Report Key8811618
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-22
Date of Report2019-08-08
Date of Event2019-06-27
Date Facility Aware2019-06-27
Date Mfgr Received2019-06-27
Device Manufacturer Date2019-04-12
Date Added to Maude2019-07-22
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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 ContactPATRICIA TUCKER
Manufacturer Street3651 BIRCHWOOD DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874151
Manufacturer G1JIANERKANG MEDICAL DRESSING CO, LTD
Manufacturer StreetNO.1, JIANERKANG ROAD, ZHIXI JIANGSU PROVINCE
Manufacturer CityJINTAN CITY 213251
Manufacturer CountryCH
Manufacturer Postal Code213251
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOWEL OR 17X24IN BLUE STERILE 4/PK
Generic NameFIBER, MEDICAL, ABSORBENT
Product CodeFRL
Date Received2019-07-22
Returned To Mfg2019-07-18
Catalog Number28700-004
Lot Number190329-16-SH
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJIANERKANG MEDICAL DRESSING CO, LTD
Manufacturer AddressNO.1, JIANERKANG ROAD, ZHIXI JIANGSU PROVINCE JINTAN CITY 213251 CH 213251


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-22

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