AIR HOSE 5.0M SCHRADER/AESCULAP SMALL GA506R

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 2019-05-07 for AIR HOSE 5.0M SCHRADER/AESCULAP SMALL GA506R manufactured by Aesculap Ag.

Event Text Entries

[144969843] (b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[144969844] It was reported the outer tube burst intraoperatively. During a surgical procedure it was reported that the outer tube of the air hose burst. No staff or patient harm. No additional information has been provided. Associated medwatch: 9610612-2019-00306.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00305
MDR Report Key8588529
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-07
Date of Report2019-06-27
Date of Event2019-04-05
Date Facility Aware2019-06-26
Date Mfgr Received2019-06-26
Device Manufacturer Date2014-10-20
Date Added to Maude2019-05-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer Phone8002581946
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 NameAIR HOSE 5.0M SCHRADER/AESCULAP SMALL
Generic NameHIGHSPEED POWER SYSTEMS
Product CodeGET
Date Received2019-05-07
Returned To Mfg2019-05-02
Model NumberGA506R
Catalog NumberGA506R
Lot Number52079373
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age53 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
10 2019-05-07

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