ALBA HEALTH TERRY TREDS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-17 for ALBA HEALTH TERRY TREDS * manufactured by Alba Health, Quality Division, Division Encompass Group.

Event Text Entries

[20527302] Pt in for out-patient surgery, changing into gown/booties, stepped on needle at toe. Originally thought to be a broken tip of suture needle. On further investigation determined to be broken tip of a sewing machine needle (possibly lodged in toe of bootie). Pt started on regimen of anti-viral drugs.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1033798
MDR Report Key559530
Date Received2004-11-17
Date of Report2004-11-08
Date of Event2004-08-25
Date Added to Maude2004-12-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALBA HEALTH TERRY TREDS
Generic NameSEWING MACHINE NEEDLE TIP
Product CodeFXP
Date Received2004-11-17
Model Number*
Catalog Number*
Lot Number*
ID NumberMANUF# 93050
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key549233
ManufacturerALBA HEALTH, QUALITY DIVISION, DIVISION ENCOMPASS GROUP
Manufacturer Address* ADDISON TX 75001 US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-11-17

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