FULL-SIZE LID W/RETENTION PLATE SILVER JK489

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-31 for FULL-SIZE LID W/RETENTION PLATE SILVER JK489 manufactured by Aesculap Ag.

Event Text Entries

[81415702] (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[81415703] Country of complaint: (b)(6). It has been reported that fluff (dark in color) was found inside the containers that have been sterilized. Components in use listed as concomitant devices are: jk489 / full-size lid w/retention plate silver. Jk441 / bottom for 1/1 container height:120mm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2017-00389
MDR Report Key6754361
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-07-31
Date of Report2017-08-07
Date of Event2017-06-02
Date Facility Aware2017-07-24
Date Mfgr Received2017-07-10
Date Added to Maude2017-07-31
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. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFULL-SIZE LID W/RETENTION PLATE SILVER
Generic NameSTERILE TECHNOLOGY
Product CodeFRG
Date Received2017-07-31
Model NumberJK489
Catalog NumberJK489
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-07-31

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