* 0013-7296

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for * 0013-7296 manufactured by Phs Custom Packaging.

Event Text Entries

[17218276] A hair was found inside a custom laparoscopic instrument pack that was ordered from a supplier.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4911604
MDR Report Key4911604
Date Received2015-07-06
Date of Report2015-07-06
Date of Event2015-06-25
Report Date2015-07-06
Date Reported to FDA2015-07-06
Date Reported to Mfgr2015-07-14
Date Added to Maude2015-07-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameTRAY, SURGICAL
Product CodeLRP
Date Received2015-07-06
Model Number*
Catalog Number0013-7296
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerPHS CUSTOM PACKAGING
Manufacturer Address42500 WINCHESTER ROAD TEMECULA CA 92590 US 92590


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-06

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