LYOPLANT ONLAY 7.5X7.5CM 1067040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-12 for LYOPLANT ONLAY 7.5X7.5CM 1067040 manufactured by Aesculap Ag.

Event Text Entries

[90179943] (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[90179945] Country of country: usa. It was reported that after a patient had a grade i meningioma procedure, the patient had a resection of the meningioma. Lyoplant onlay was used at the end of the surgery. Mri reveled a seroma post.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2017-00494
MDR Report Key6944053
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-10-12
Date of Report2017-11-01
Date of Event2017-09-07
Date Facility Aware2017-09-29
Date Mfgr Received2017-09-19
Device Manufacturer Date2017-06-24
Date Added to Maude2017-10-12
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 NameLYOPLANT ONLAY 7.5X7.5CM
Generic NameLYOPLANT ONLAY
Product CodeMVA
Date Received2017-10-12
Model Number1067040
Catalog Number1067040
Lot Number216475
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age10 MO
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 2017-10-12

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