FDA.reportPublic FDA data

MAUDE MDR 390789

MDR report key
390789
Report number
1037420-2002-00004
Event key
0
Event type
3
Date of event
2002-03-19
Date received
2002-04-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
200 DEBUSK LANE POWELL TN 37849 US
Phone
865-865-8659
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
113982000 AB BNDR 12" UNIV 46-62DBG DEBQL CHEST PRODUCTSDEROYAL INDUSTRIES, INC.FSDNA13982000UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-04-2201. O

Event Narratives#

D

Patient 1

A PATIENT REPORTED EXPERIENCING A RASH AFTER WEARING A FOUR (4) PANEL ABDOMINAL BINDER FOLLOWING HERNIA SURGERY. PATIENT REPORTEDLY HAS AN ADHESIVE TAPE ALLERGY AND THIS INFORMATION IS NOTED ON PATIENT'S CHART. PATIENT REPORTEDLY HAS WASHED THREE (3) TIMES TO TRY TO REMOVE THE ITCH AND IT WAS NOT HELPING. PATIENT WANTED TO KNOW IF COMPANY STAFF COULD RECOMMEND SOMETHING IN WHICH TO WASH THE PRODUCT. PATIENT CALLED DOCTOR WHO INSTRUCTED PATIENT TO USE BENADRYL FOR THE RASH UNTIL FOLLOW UP VISIT IN 3/2002. REPLACEMENT PRODUCTS WILL BE SENT.