PRIMELINE 1/1 LID BLUE JP002

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 2018-02-20 for PRIMELINE 1/1 LID BLUE JP002 manufactured by Aesculap Ag.

Event Text Entries

[100560428] (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[100560429] Country of complaint: (b)(6). It was reported that there were cracks on the inside of the cover.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00076
MDR Report Key7282430
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-20
Date of Report2018-03-09
Date Facility Aware2018-02-13
Date Mfgr Received2018-01-26
Device Manufacturer Date2010-01-01
Date Added to Maude2018-02-20
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 NamePRIMELINE 1/1 LID BLUE
Generic NameSTERILE TECHNOLOGY
Product CodeKCT
Date Received2018-02-20
Returned To Mfg2018-02-06
Model NumberJP002
Catalog NumberJP002
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age8 YR
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 2018-02-20

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