FDA Adverse Event Injury Summary report: N

SURGICAL TOOLS

MDR report key: 1963979 · Received January 13, 2011

Report

Report Number
MW5019021
Event Type
Injury
Date Received
January 13, 2011
Manufacturer
SMITH AND NEPHEW
Product Code
LXH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON (B)(6) 2010 - PRE-OPERATIVE LAB AND TESTS PERFORMED DR. (B)(6), MD. ON (B)(6) 2010 - ROTATOR CUFF SURGERY WAS PERFORMED BY DR (B)(6), MD AT (B)(6) CTR (ADJACENT TO AND AFFILIATED WITH (B)(6) CLINIC). (B)(6) RECEIVED A PRESCRIPTION TO ENGAGE IN PHYSICAL THERAPY FOR THE DAY AFTER SURGERY AT THEIR FACILITY. ON (B)(6) 2010 - VISITED PHYSICAL THERAPY TO REVIEW PROCESS FOR REHABILITATION. (B)(6), THE LEAD THERAPIST, WHILE DISTRACTED BY OTHER DUTIES, CAUSED SEVERE SHOULDER PAIN AT SURGICAL SITES. (B)(6) HUSBAND, (B)(6), LATER REQUESTED AND RECEIVED WRITTEN THERAPY STEPS TO TAKE HOME. PAIN CONTINUED AND CAUSED PROBLEMS WITH SLEEPING. NUMEROUS NIGHTS, (B)(6) WOULD TRY TO PROVIDE SOME RELIEF WITH BACK MASSAGE. ON (B)(6) 2010 - SEVERE CHILLS AND SWEATS - AWOKE SOAKING WET. ON (B)(6) 2010 - SIX WEEK CHECK-UP WITH DR (B)(6). TOLD DR (B)(6) ABOUT CHILLS AND SWEATS, BUT HE DIDN'T BELIEVE IT WAS RELATED TO THE SURGERY. TOLD DR (B)(6) ABOUT THE SEVERE PAIN IN RIGHT SHOULDER, BUT HE THOUGHT THAT MOBILITY WAS GOOD AND PROGRESS WAS ON SCHEDULE. HE SAID HE HAD DONE 2000 ROTATOR CUFF SURGERIES WITHOUT ANY PROBLEMS. ABOUT (B)(6) 2010 - DUE TO SEVERE PAIN IN SHOULDER WE DECIDED TO GO TO ER. THE ER AT (B)(6) CLINIC ADMINISTERED MORPHINE, BUT PERFORMED NO TESTS. FROM (B)(6) 2010-(B)(6) 2010 - (B)(6) CALLED DR (B)(6) ASST, (B)(6), SEVERAL TIMES TO REQUEST APPT TO FIND SOMETHING EFFECTIVE FOR THE PAIN AND (B)(6) ACCUSED HER OF BEING A DRUGGIE AND WAS REFUSED AN APPT WITH (B)(6). (B)(6) LATER LEARNED (B)(6) MADE AN APPT WITH (B)(6), DR (B)(6), WITHOUT TELLING HER. ON (B)(6) 2010 - (B)(6) LEARNED FROM (B)(6) THAT I HAD AN APPT FOR (B)(6) 2010. ON (B)(6) 2010 - DR (B)(6) ORDERED AN MRI ON MY SHOULDER AND PRESCRIBED DARVOCET. PAIN IN RIGHT SHOULDER WAS SO SEVERE IT PREVENTED (B)(6) FROM SITTING STRAIGHT. THAT NIGHT SHE HAD A REACTION TO DARVOCET CAUSING SEVERE HYPERTENSION AND WAS UNABLE TO SLEEP FOR 24 HRS. ON (B)(6) 2010 - (B)(6) HAD MRI AT (B)(6) CLINIC WHICH DISCLOSED MASSIVE INFECTION IN RIGHT SHOULDER. ON (B)(6) 2010 - WENT TO (B)(6) HOSP ER TO GET PAIN RELIEF. THEY ADMINISTERED MORPHINE FOR RELIEF. THEY CONTACTED DR (B)(6) AS NO EFFECTIVE PRESCRIPTION FOR PAIN MEDICATION WAS PROVIDED BY DR AT (B)(6) ER. ON (B)(6) 2010 - DR (B)(6) CALLED TO SET AN APPT FOR (B)(6) 2010 AND GAVE US HIS PERSONAL CELL PHONE NUMBER FOR EMERGENCIES DUE TO OUR DIFFICULTY GETTING PAST HIS ASST. ON (B)(6) 2010 - DR (B)(6) GAVE US THE RESULTS OF THE MRI WHICH REQUIRED AN IMMEDIATE ADMISSION TO DAY SURGERY TO FLUSH THE INFECTION OUT OF THE SURGICAL SITE. ON (B)(6) 2010 - (B)(6) HAD MIGRAINES AND WAS IN MIND NUMBING PAIN FROM THE TIME OF SURGERY THROUGH (B)(6). ON (B)(6) 2010 - AN AID DROPPED AN IV BAG ON THE FLOOR AND QUITE A BIT RAN OUT. SHE TOLD AN ORDERLY TO MOP UP THE SPILL AND WITHOUT CONCERN ADMINISTERED THE SALINE SOLUTION TO (B)(6) EVEN AFTER (B)(6) AND THE ORDERLY EXPRESSING CONCERN FOR ITS POSSIBLE CONTAMINATION. THE AID SAID IT WAS NOT AN ISSUE. ON (B)(6) 2010 - A NURSE NAMED (B)(6) GAVE (B)(6) A LARGE NUMBER OF A VARIETY OF PILLS WHICH SHE HAD FOUND AT THE NURSES' STATION. (B)(6) SAID SHE DIDN'T KNOW WHOSE PILLS THEY WERE, BUT SHE THOUGHT THEY WERE FOR ME. (B)(6) HAD BROUGHT TWO MEDICATIONS FROM HOME THAT HE HAD BEEN TOLD TO BRING BECAUSE THE PHARMACY DID NOT CARRY THEM. THE NURSING STAFF REFUSED TO PROVIDE THE ASTHMA MEDICATION THAT (B)(6) BROUGHT FROM HOME. (B)(6) REQUESTED AN AID CALL A NURSE SUPERVISOR. THEY SUBSEQUENTLY TOLD (B)(6) TO REMOVE THE PILLS AND TOOK CONTROL OF (B)(6) CARE. WE WERE TOLD (B)(6) HAD AN APPT WITH AN (B)(6) DISEASE DOCTOR AT 1:00 PM THAT DAY AND THEY WERE SUPPOSED TO INFUSE TWO ANTIBIOTICS BEFORE WE LEFT, THE FIRST (B)(6) RECEIVED WHILE IN THE HOSP. ON (B)(6) 2010 - WE WENT TO DR (B)(6) OFFICE TO HAVE TRAINING ON HOW (B)(6) WAS TO INFUSE TWO DAILY ANTIBIOTICS FOR (B)(6) TREATMENT AND OBTAIN THE MATERIALS AND MEDICATION. THE INFUSIONS WERE TO BE ADMINISTERED FOR UP TO 6 WEEKS. DR (B)(6) PROVIDED A COPY OF THE BLOOD TEST RESULTS AND ADVISED US THAT THE INFECTION WAS MORE OFTEN FOUND BELOW THE WAIST AS IN A LOWER GI TRACT INFECTION. ON (B)(6) 2010 - (B)(6) SPOKE TO (B)(6) MD DURING THE VISIT AT HIS PAIN MGMT OFFICE AND EXPRESSED DISMAY AT NOT BEING GIVEN ANY PAIN MGMT DIRECTION OR MEDICATION AFTER THEY WERE ADVISED THAT DARVOCET WAS NOT VIABLE AND THEIR RESPONSE WAS "THEY TRIED TO CALL BACK". THE ASST SAID SHE TRIED TO CALL BACK DURING (B)(6) SURGERY, BUT COULDN'T REACH HER. DURING THIS VISIT (B)(6) WAS GOING TO GIVE THE DARVOCET BACK, HAVING ONLY TAKEN ONE TABLET, BUT IT WAS REFUSED SO WE DISCARDED THEM AS WASTE THERE. DURING THIS VISIT DR (B)(6) ACKNOWLEDGED THAT "THEY WERE NOT CONCIERGE DOCTORS". ON (B)(6) 2010 - (B)(6) CALLED (B)(6) OFFICE TO ASK WHAT THEIR POLICY WAS ABOUT RESPONDING TO ADVERSE REACTIONS TO DARVOCET. (B)(6) SAID HE WOULD CHECK, BUT HAS YET TO CALL BACK WITH A RESPONSE. ON (B)(6) 2010 - (B)(6) CALLED THE MAIN OFFICE OF (B)(6) CLINIC AND BOTH (B)(6) AND (B)(6) WERE GIVEN THE DETAILS OF POOR MEDICAL SERVICE. THEY SAID THEY WOULD CHECK INTO THE SITUATION AND NO ONE HAS RESPONDED. FROM (B)(6) 2010-(B)(6) 2010 - (B)(6) GAVE DAILY INFUSIONS OF TWO ANTIBIOTICS TO (B)(6) AND WE MADE WEEKLY VISITS TO DR (B)(6) OFFICE FOR RESUPPLY OF MEDICATION AND RETEST OF BLOOD. ON (B)(6) 2011 - (B)(6) HAS BEEN ADVISED BY DR (B)(6) THAT THERE SHOULD BE TWO MORE F/U VISITS TO MONITOR HER PROGRESS AFTER THE (B)(6) COMPLICATIONS. THE NEXT VISIT IS SCHEDULED FOR (B)(6) 2011. CONCERNS: DUE TO THE NUMEROUS APPARENT LAPSES IN MEDICAL PROTOCOL AND INFECTION FOLLOWING THE (B)(6) 2010 SURGERY, WE HAVE SERIOUS RESERVATIONS ABOUT THE GENERAL MEDICAL MGMT AT (B)(6) CTR, (B)(6) AND (B)(6) CLINIC, WHICH ARE ALL WITHIN THE SAME MEDICAL COMPLEX AND OPERATE INTER-RELATEDLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SURGICAL TOOLS SURGICAL TOOLS LXH SMITH AND NEPHEW UNK UNK
2 SCREWS SCREWS HWC SMITH & NEPHEW UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 66 YR Other GENERIC DARVOCET