InjuryLSB
DONJOY
Received Jun 18, 2015 · Event occurred May 13, 2015
Report 9616086-2015-00014 · MDR key 4858602
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Anaphylactic Shock
- Unspecified Infection
Narrative
Description of Event or Problem
COMPLAINT RECEIVED FROM CUSTOMER THAT ALLEGES "ANAPHYLACTIC SHOCK AND INFECTED SORES FOLLOWING WEARING THE LATERAL J BRACE. I HAVE TWO OF THE.... I WAS SEEN FOR TREATMENT AND GIVEN CIPRO CAPSULES, ROCEPHIN 1000MG INJECTION, AND BACTROBAN OINTMENT". QUESTIONAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PT. DEVICE NOT RETURNED TO MFR FOR EVAL.