inforMED
FSD

ABDOMINAL BINDER

Received Jun 18, 2014 · Event occurred Jun 12, 2014

Report 3893467 · MDR key 3893467

Device

Generic name

Binder, Abdominal

Model number

*

Catalog number

A131056

Lot number

35159679

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

31 YR

  • Itching Sensation
  • Rash

Narrative

Description of Event or Problem

PATIENT DEVELOPED A REACTION (RASH) ON THE ABDOMEN AND BACK WHERE THE ABDOMINAL BINDER HAD BEEN IN DIRECT CONTACT WITH THE PATIENT'S SKIN. PATIENT COMPLAINED OF ITCHY RASH ON HER ABDOMEN AND ON HER BACK. THE RASH WAS IN -THE SHAPE OF THE BINDER; PATIENT SAID THAT THE DOCTOR KNOWS ABOUT IT AND GAVE HER A AND D OINTMENT FOR IT. PATIENT GIVEN BENADRYL P.O. FOR THE ITCHING.THIS FACILITY HAS HAD ONGOING ISSUES WITH THIS DEVICE OVER THE LAST YEAR. RASHES HAVE DEVELOPED AFTER THE ABDOMINAL BINDER IS PLACED. PATIENTS IN ALL AREAS OF THE FACILITY WHERE THE PRODUCT IS USED HAVE BEEN AFFECTED. THERE IS NO APPARENT VISUAL DEFECT TO THE DEVICE. THE RASH DEVELOPS WITHIN 24 HOURS AFTER PLACEMENT ON THE PATIENT. AFFECTED PATIENTS ARE NOT ALLERGIC TO LATEX AND HAVE NO PREVIOUSLY REPORTED ALLERGIES. SOME PATIENTS HAVE REQUIRED MEDICAL INTERVENTION FOR THE RASH. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. CONTRIBUTING FACTORS FOR THE RASH HAVE NOT BEEN ABLE TO BE DETERMINED. THE DEVICES ARE STORED IN TEMPERATURE CONTROLLED ENVIRONMENTS AND ARE SEALED IN THEIR INDIVIDUAL PACKAGES UNTIL NEEDED. MULTIPLE LOT NUMBERS ARE INVOLVED.