MINI-SIZE LID W/RETENTION PLATESILVER JK174

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 2018-03-13 for MINI-SIZE LID W/RETENTION PLATESILVER JK174 manufactured by Aesculap Ag.

Event Text Entries

[102339974] (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[102339975] Country of complaint: (b)(6). It is reported that the seals are faulty. Components in use listed as concomitant devices are: jk174 / mini-size lid w/retention platesilver. Jk188 / bottom f/mini container height: 57 mm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00113
MDR Report Key7334583
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-13
Date of Report2018-03-13
Date Facility Aware2018-03-12
Date Mfgr Received2016-07-06
Date Added to Maude2018-03-13
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 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 NameMINI-SIZE LID W/RETENTION PLATESILVER
Generic NameMINI CONTAINER BOTTOMS AND LIDS
Product CodeFRG
Date Received2018-03-13
Returned To Mfg2016-07-25
Model NumberJK174
Catalog NumberJK174
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-13

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