CHEST SUPPORT WITH PAD A-71301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for CHEST SUPPORT WITH PAD A-71301 manufactured by Allen Medical Systems.

Event Text Entries

[175033119] Chest pad broke during surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9590524
MDR Report Key9590524
Date Received2020-01-15
Date of Report2020-01-07
Date of Event2020-01-02
Report Date2020-01-07
Date Reported to FDA2020-01-07
Date Reported to Mfgr2020-01-15
Date Added to Maude2020-01-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHEST SUPPORT WITH PAD
Generic NameTABLE AND ATTACHMENTS, OPERATING-ROOM
Product CodeBWN
Date Received2020-01-15
Catalog NumberA-71301
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALLEN MEDICAL SYSTEMS
Manufacturer Address100 DISCOVERY WAY ACTON MA 01720 US 01720


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-15

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