inforMED
DeathOGJ

CLINT PHARMACEUTICALS SINGLE-SHOT EPIDURAL TRAY

Received Aug 16, 2013 · Event occurred Jul 1, 2013

Report MW5031523 · MDR key 3305269

Device

Generic name

Epidural Injection Procedure Tray

Catalog number

NA

Lot number

2231031

Product problems

  • Insufficient Device Problem Information

Patient

78 YR

  • Pulmonary Embolism
  • Bacterial Infection
  • Fever
  • Inflammation
  • Pain
  • Meningitis

Narrative

Description of Event or Problem

A (B)(6) YEAR OLD MALE UNDERWENT A CATHETER-ASSISTED CAUDAL EPIDURAL STEROID INJECTION ON (B)(6) 2013 WITHOUT INCIDENT OR COMPLICATION. ON (B)(6) 2013, PT ARRIVED AT OFFICE BEFORE OPEN HOURS WANTING TO BE SEEN. HE DID NOT WAIT, AND REPORTED TO A LOCAL ER, COMPLAINING OF INCREASED LOW BACK PAIN FOR 3 DAYS. HE HAD BEEN NEARLY PAIN-FREE OF HIS LOW BACK PAIN FOR 7 DAYS FOLLOWING THE PROCEDURE. HE WAS TREATED FOR A "PHLEGMON AT THE S4 LEVEL IN THE SUBCUTANEOUS TISSUES" WITH IV ANTIBIOTICS AND SENT HOME FROM THE ER (AT (B)(6)). HE PRESENTED TO THE SAME ER AGAIN LATER THAT DAY WITH FEVER AND WORST BACK PAIN, AND WAS TRANSFERRED TO (B)(6). HE WAS ADMITTED AS INPATIENT FOR ANTIBIOTIC THERAPY, AND IMPROVED UNTIL (B)(6) 2013 WHEN SUFFERED A PULMONARY EMBOLISM AND WAS ADMITTED TO ICU. ALL CULTURES NEGATIVE TO THIS POINT. LUMBAR PUNCTURE PERFORMED (B)(6) 2013 - CLEAR YELLOW FLUID OBTAINED. THE PT WAS TREATED WITH ANTIBIOTICS FOR PSEUDOMONAS MENINGITIS. HE DETERIORATED AND EXPIRED ON (B)(6) 2013.