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 2016-10-14 for FULL-SIZE LID W/RETENTION PLATE SILVER JK489 manufactured by Aesculap Ag.

Event Text Entries

[57438260] (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[57438261] Country of complaint: (b)(6). It was reported that while preparing for a total knee arthroplasty surgery, when opening the cover to use instruments the filter with the holder dropped inside the container. There was a two hour delay in surgery in order to complete a sterilization on the instruments. The procedure was completed without any harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2016-00848
MDR Report Key6029699
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-10-14
Date of Report2017-10-30
Date of Event2016-09-14
Date Facility Aware2016-09-30
Date Mfgr Received2016-09-15
Date Added to Maude2016-10-14
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 Received2016-10-14
Returned To Mfg2016-09-23
Model NumberJK489
Catalog NumberJK489
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2016-10-14

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