inforMED

DME COMPANY BECKER ORTHOPEDICS

Received Aug 18, 2014 · Event occurred Jul 19, 2014

Report 4239349 · MDR key 4239349

Device

Generic name

Stocking, Elastic

Manufacturer

*

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Insufficient Device Problem Information

Patient

65 YR

  • Necrosis
  • Tissue Damage

Narrative

Description of Event or Problem

THIS PATIENT CAME TO THE ED WITH GANGRENE AND UNDERWENT AN EMERGENT BKA (BELOW KNEE AMPUTATION). PATIENT WAS QUITE ILL AND HAD NUMEROUS COMORBIDITIES.THE PATIENT HAD A BKA AND A STUMP SHRINKER IN PLACE THAT MAY HAVE CONTRIBUTED TO NECROSIS AND HARM. THIS RESULTED IN ADVANCEMENT TO AN AKA (ABOVE KNEE AMPUTATION). MD SUGGESTION TO PREVENT ANY POTENTIAL PROBLEMS: MANUFACTURER SHOULD UPDATE THEIR PROCESSES TO INCLUDE CONSULTING WITH A PATIENT'S RN WHEN THEY PLACE AN ORTHOTIC SHRINKER ON A PATIENT.