NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER 14104

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-05 for NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER 14104 manufactured by Hollister Incroporated.

Event Text Entries

[135032693] Sample not returned so a sample evaluation is not possible. Lot number not known so dhr review is not possible. Trend data reviewed and no adverse trend observed. The root cause of the reported round, raised bumps on the end user's peristomal skin cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


[135032694] It was reported that the end user experienced red, raised, painful bumps on her peristomal skin under the new image barrier. She denies any effluent leakage onto her skin. The doctor thought it might be a yeast infection and prescribed diflucan oral medication. The bumps remain so she will try a different barrier formulation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119193-2019-00005
MDR Report Key8305820
Report SourceCONSUMER
Date Received2019-02-05
Date of Report2019-02-04
Date of Event2019-01-07
Date Mfgr Received2019-01-29
Date Added to Maude2019-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLINDA WISOWATY
Manufacturer Street2000 HOLLISTER DRIVE
Manufacturer CityLIBERTYVILLE IL 600483781
Manufacturer CountryUS
Manufacturer Postal600483781
Manufacturer Phone8476802170
Manufacturer G1HOLLISTER INCORPORATED
Manufacturer Street366 DRAFT AVENUE
Manufacturer CitySTUARTS DRAFT VA 244779998
Manufacturer CountryUS
Manufacturer Postal Code244779998
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER
Generic NameNEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER
Product CodeEXB
Date Received2019-02-05
Catalog Number14104
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLLISTER INCROPORATED
Manufacturer Address2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-02-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.