inforMED
FSD

ABDOMINAL BINDER

Received Jul 2, 2013 · Event occurred Jul 1, 2013

Report 3215398 · MDR key 3215398

Device

Generic name

Binder, Abdominal

Model number

*

Catalog number

A131067

Lot number

31981358

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

31 YR

  • Rash

Narrative

Description of Event or Problem

ABDOMINAL BINDER CAUSED MACULOPAPULAR RASH ON PATIENT'S SKIN. BINDER REMOVED. PT REQUIRED BENADRYL AND HYDROCORTISONE. THIS FACILITY HAS HAD MORE THAN 6 SIMILAR EVENTS WITH THIS PRODUCT IN THE LAST 5 MONTHS. PRODUCT STATES LATEX FREE. THE FACILITY REPORTS THIS TYPE OF REACTION HAS BEEN SEEN IN PATIENTS WITH C-SECTIONS AS WELL AS VAGINAL DELIVERIES; THUS, STAFF DO NOT BELIEVE THAT THERE IS A REACTION TO THE SKIN PREP USED FOR C-SECTION DELIVERIES BECAUSE THE PREP IS NOT USED IN A VAGINAL DELIVERY. ALSO, STAFF HAVE STATED IN PREVIOUS INCIDENTS THAT THE RASH OCCURS ON AREAS WHICH DOES NOT HAVE THE SKIN PREP BUT DOES HAVE CONTACT WITH THE BINDER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ABDOMINAL WALL PROTECTION/ SUPPORT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.