inforMED
FSD

ABDOMINAL BINDER

Received Sep 23, 2013 · Event occurred Jul 23, 2013

Report 3420136 · MDR key 3420136

Device

Generic name

Binder, Abdominal

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

35 YR

  • Rash

Narrative

Description of Event or Problem

PT DEVELOPED RASH ON STOMACH FROM USE OF ABDOMINAL BINDER. THIS FACILITY HAS HAD MULTIPLE SIMILAR EVENTS WITH THIS PRODUCT IN THE LAST 6 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 DOES 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 HAS STATED IN PREVIOUS INCIDENTS THAT THE RASH OCCURS ON AREAS WHICH DOES NOT HAVE THE SKIN PREP BUT DOES HAVE CONTACT WITH THE BINDER. PATIENTS WITH AND WITHOUT KNOWN ALLERGIES HAVE BEEN AFFECTED. THE MANUFACTURER HAS BEEN NOTIFIED. THEY ARE UNAWARE OF ANY OTHER COMPLAINTS LIKE THIS.