BARRIER EXTRA PROTECTION PLUS GOWN, EXTRA LARGE 0541

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-05-21 for BARRIER EXTRA PROTECTION PLUS GOWN, EXTRA LARGE 0541 manufactured by Molnlycke Health Care, Inc..

Event Text Entries

[18145331] Initial report from territory sales manager, concerning an account that had just converted from using an entire fluid impervious gown to a fluid zoned impervious gown. The customer alleged strikethrough of fluid in the abdomen. A total of five incidents were reported form this hospital for the following: 1) bowel resection, 2) incision and drape (i&d) - two surgeons, 3) total hip replacement and 4) severe gunshot wound. This report is filed for no. 4 above; ms. Fitzpatrick, visited the hospital and was unable to gather additional info for this report. No bloodborne pathogen exposure was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523357-2003-00005
MDR Report Key461768
Report Source07
Date Received2003-05-21
Date of Report2003-05-20
Date of Event2003-04-20
Date Mfgr Received2003-04-22
Date Added to Maude2003-05-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Manufacturer ContactLINDA HENDRICKS, MANAGER
Manufacturer Street826 NEWTOWN-YARDLEY ROAD
Manufacturer CityNEWTOWN PA 18940
Manufacturer CountryUS
Manufacturer Postal18940
Manufacturer Phone8008824582
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBARRIER EXTRA PROTECTION PLUS GOWN, EXTRA LARGE
Generic NameGOWN, SURGICAL
Product CodeFYE
Date Received2003-05-21
Model NumberNA
Catalog Number0541
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key450711
ManufacturerMOLNLYCKE HEALTH CARE, INC.
Manufacturer Address826 NEWTOWN-YARDLEY RD. NEWTOWN PA 18940 US
Baseline Brand NameBARRIER SURGICAL GOWN
Baseline Generic NameGOWN, SURGICAL
Baseline Catalog No0541
Baseline ID9541
Baseline Device FamilySURGICAL GOWNS
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]60
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK760903
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-05-21

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