FDA.reportPublic FDA data

MAUDE MDR 406403

MDR report key
406403
Report number
1037420-2002-00011
Event key
0
Event type
3
Date of event
2002-06-21
Date received
2002-07-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

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
113992000 AB BNDR 9" UNIV 46-62DBG DEBQL CHEST PRODUCTSDEROYAL INDUSTRIES, INC.FSDNA13992000UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-07-2201. O

Event Narratives#

D

Patient 1

A PT DEVELOPED A RASH AFTER USING AN ABDOMINAL BINDER. PT DOESN'T KNOW IF PT IS ALLERGIC TO LATEX. PT HAS NEVER HAD A REACTION BEFORE THE BINDER WAS GIVEN TO PT AT HOSPITAL FOLLOWING HYSTERECTOMY SURGERY. PT WORE IT FROM FRIDAY UNTIL MONDAY WHEN PT CAME HOME. AFTER TAKING A SHOWER, THE RASH GOT WORSE. THE DR HAS GIVEN PT MEDICATION FOR THE RASH, AND PT NO LONGER HAS TO WEAR THE BINDER. NO REPLACEMENT BINDER IS NEEDED.