TUTOPATCH? DURAL SUBSTITUTE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-04 for TUTOPATCH? DURAL SUBSTITUTE manufactured by Tutogen Medical Gmbh.

Event Text Entries

[188686871] Unique identifiers were not provided in order to conduct a comprehensive records re-review. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[188686872] Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020. An adverse event was reported through a post market survey for tutopatch? For dura substitution application via qualtrics survey software. The doctor indicated that the doctor indicated that during his 15 years of using the product, < 1% of his patients/cases have experienced infection, inflammation and brain abscess formation. Additional information has been requested. To date, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002924436-2020-00009
MDR Report Key9788452
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-04
Date of Report2020-03-04
Date Mfgr Received2020-02-04
Date Added to Maude2020-03-04
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 ContactMRS LEILA KELLY
Manufacturer Street11621 RESEARCH CIRCLE
Manufacturer CityALACHUA, FL
Manufacturer CountryUS
Manufacturer Phone4188888436
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTUTOPATCH? DURAL SUBSTITUTE
Generic NameDURAL GRAFT SUBSTITUTE
Product CodeGXQ
Date Received2020-03-04
Lot NumberNOT PROVIDED
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTUTOGEN MEDICAL GMBH
Manufacturer AddressINDUSTRIESTRABE 6 NEUNKIRCHEN AM BRAND 97077 GM 97077


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-04

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