ADAPT CERARING FLAT BARRIER RING 8805

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 2018-10-02 for ADAPT CERARING FLAT BARRIER RING 8805 manufactured by Hollister Incorporated.

Event Text Entries

[122349555] No sample received and no lot number provided. Without the sample or lot number hollister is unable to perform a full investigation regarding the skin issue. This will continue to be monitored in hollister's post marketed complaint system and actions will be taken if/when indicated.
Patient Sequence No: 1, Text Type: N, H10


[122349556] It was reported that an end user developed red, blistering and bleeding peristomal skin 1 1/2 hours after using the adapt ceraring for the first time. The end user applied hot compresses and the bleeding stopped. The area improved but she went to the er that evening. They applied and then prescribed lidocaine topical ointment for her to apply at home. She stopped using the adapt ceraring and the peristomal skin is fine now.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119193-2018-00037
MDR Report Key7926595
Report SourceCONSUMER
Date Received2018-10-02
Date of Report2018-10-02
Date of Event2018-09-27
Date Mfgr Received2018-09-28
Date Added to Maude2018-10-02
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 ContactMS. LINDA WISOWATY
Manufacturer Street2000 HOLLISTER DRIVE
Manufacturer CityLIBERTYVILLE. 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 NameADAPT CERARING FLAT BARRIER RING
Generic NameADAPT CERARING FLAT BARRIER RING
Product CodeEXB
Date Received2018-10-02
Catalog Number8805
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLLISTER INCORPORATED
Manufacturer Address2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-02

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