inforMED
OtherLPQ

SAFHS 2000 MOU ASSEMBLY

Received Jul 25, 2013 · Event occurred Jun 7, 2013

Report 3010203571-2013-00002 · MDR key 3311016

Device

Generic name

Bone Growth Stimulator/lpq

Manufacturer

Bioventus Llc

Model number

NA

Catalog number

UNK

Lot number

NA

Product problems

  • Patient-Device Incompatibility

Patient

80 YR

  • Local Reaction

Narrative

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE EXOGEN DEVICE, THE PT EXPERIENCED A CASE OF ECZEMA. THE PHYSICIAN RELATES THE REACTION TO THE GEL. THIS COMPLAINT WAS REPORTED TO THE PMDA ON (B)(6) 2013.