BAXTER - CONVERTORS * 3274

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-04 for BAXTER - CONVERTORS * 3274 manufactured by Baxter - Convertors/hospital Supply Division.

Event Text Entries

[70940] Mri showed metal artifact pt questioned, denyed any metal, bb, etc. When finished broken sewing machine needle found woven in "comfort bouffant cap" elastic band. Significant hazard potential.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number117747
MDR Report Key117747
Date Received1997-09-04
Date of Report1997-06-13
Date of Event1997-06-11
Date Added to Maude1997-09-09
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 NameBAXTER - CONVERTORS
Generic NameCOMFORT BOUFFANT CAP
Product CodeFYF
Date Received1997-09-04
Returned To Mfg1997-06-13
Model Number*
Catalog Number3274
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key115482
ManufacturerBAXTER - CONVERTORS/HOSPITAL SUPPLY DIVISION
Manufacturer Address82 INVERNESS DR. ENGLEWOOD CO 80112 US
Baseline Brand NameCAP, BOUFFANT, SPUNDBONDED, BLUE
Baseline Generic NameBOUFFANT CAP
Baseline Model No3274
Baseline Catalog No3274
Baseline IDNA
Baseline Device FamilyAPPAREL
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK800511
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-09-04

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