PRIMLINE LID

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 2018-10-02 for PRIMLINE LID manufactured by Aesculap Ag.

Event Text Entries

[122476874] (b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[122476875] It was reported that sets sterilized using primeline lids have resulted in wet sets. There was no patient injury reported, however, there was a surgical delay of 30 to 40 minutes. It was not reported if the patient was under anesthesia during the delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00457
MDR Report Key7928166
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-10-02
Date of Report2018-10-02
Date of Event2018-09-11
Date Facility Aware2018-09-11
Date Mfgr Received2018-09-12
Date Added to Maude2018-10-02
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 CityTUTTLINGGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIMLINE LID
Generic NameSTERILIZATION CONTAINER LID
Product CodeKCT
Date Received2018-10-02
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-02

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