inforMED
MalfunctionFSD

DEROYAL ABDOMINAL BINDER

Received Jun 3, 2014 · Event occurred May 13, 2014

Report 3005225477-2014-00013 · MDR key 3957948

Device

Generic name

Binder, Abdominal

Manufacturer

Deroyal Guatemala

Catalog number

A131067

Lot number

33405670

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Rash

Narrative

Description of Event or Problem

PATIENT DEVELOPED RASH FROM ABDOMINAL BINDER. THIS FACILITY HAS HAD ONGOING ISSUES WITH THE DEVICE. RASHES HAVE DEVELOPED AFTER THE ABDOMINAL BINDER IS PLACED ON BOTH C-SECTION AND VAG DELIVERY PATIENTS. THIS PRODUCT ALSO IS USED AT THIS FACILITY IN THE SURGICAL UNIT. UNTIL RECENTLY, SURGICAL PATIENTS HAD NOT BEEN AFFECTED. HOWEVER, ONE CASE OF A SURGICAL PATIENT WITH A SIMILAR EVENT DID HAPPEN RECENTLY. AFFECTED PATIENTS ARE NOT ALLERGIC TO LATEX AND HAVE NO PREVIOUSLY REPORTED ALLERGIES. SOME PATIENTS HAVE REQUIRED MEDICAL INTERVENTION FOR THE RASH.