DME COMPANY BECKER ORTHOPEDICS
Received Aug 18, 2014 · Event occurred Jul 19, 2014
Report 4239349 · MDR key 4239349
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.