SENSI-CARE PROTECTIVE BARRIER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2014-08-14 for SENSI-CARE PROTECTIVE BARRIER manufactured by .

Event Text Entries

[52487178] Based on the available information, this event is deemed a serious injury. No additional patient/event details have been provided to date. A return sample for the evaluation is not expected. Should additional information become available, a follow-up report will be submitted. There are three (3) cases associated with this product, therefore a separate fda 3500a form has been generated to address the other two (2) cases. The actual date of event is unknown, so the date used was the date convatec became aware. Product therapeutic indications are to temporarily protect and help relieve chapped or cracked skin and lips; to treat and prevent diaper rash; and protect minor skin irritation associated with diaper rash and to help seal out wetness. The lot number was not provided. Therefore, we are unable to determine the specific manufacturing site. Reported to the fda on august 14, 2014.
Patient Sequence No: 1, Text Type: N, H10


[52487179] Rejected by axc4 to confirm drug or device. The facility wound care manager reported that three (3) patient developed pressure ulcers to the sacra-buttock area. The wound care manager stated the product was being utilized for contact dermatitis in the sacral area dn the nurses were applying the protective barrier to wet moist areas. The depth of the pressure ulcers were assessed as stage iii or stage iv although it was reported the staff were having difficulty removing the product and were unable to assess the skin. The wound care manager did not indicate additional treatment for the pressure ulcers. The territory manager indicated the facility had elected to switch to a new product and were advised they had to used the product in stock before switching to the new product. He reported no safety issues was involved, however educational opportunities for the application of product, how to assess skin, and reapplication of the product were identified.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1049092-2014-00400
MDR Report Key4023614
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2014-08-14
Date of Report2014-07-23
Date of Event2014-07-23
Date Mfgr Received2014-07-23
Date Added to Maude2014-08-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMATTHEW WALENCIAK, INT.ASSOC.DIR.
Manufacturer Street211 AMERICAN AVE.
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSENSI-CARE PROTECTIVE BARRIER
Generic NameTOPICAL, 4 OUNCE SIZE; QUANTITY PER CASE: 24 TUBES
Product CodeNEC
Date Received2014-08-14
Lot NumberUNK
ID NumberNDC: 43553-3256-4
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-08-14

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