FDA Adverse Event Injury Summary report: N

ACE/GAUZE CADT PLASTER

MDR report key: 1395075 · Received May 26, 2009

Report

Report Number
MW5011233
Event Type
Injury
Date Received
May 26, 2009
Report Date
May 26, 2009
Product Code
LGF
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

"DR RUSHED TO PLACE UNK ARTHODESIS, OVER CAPRS, LET KID DRESS IT, 5 MINUTES PER REPORT, CADT DROOPED,, TEN DAYS LATER FOUND AND TOLD KID TO FIX IT AN LEFT --- WRAPPED TIGHT ELBOW TO FINGERS THEN PLACED CLEANER BOTTLE, ON TRAY WET PLASTER WRAP ON TOP RE SET WRIST INTO HI ARC, WRAPPED TIGHTLY WITH ACE TYPE BANDAGES, AS PAIN ROSE TO INTOLERABLE, RETURNED TO CLINIC XRAYED REPORTED FOREARM NOT BROKE REMEDIAL PAIN TOUGHEN UP. TEN DAYS LATER UNWRAPPED DEAD HAND, CHERRY TO BROWN, SIGNED FORM AS HEALING NICELY, VERY IRREGULAR SIGNATURE. EIGHT MONTHS THERAPY 3 TIMES WEEK, CONFRONTED SURGEON AND WC DR, RESIGNED, REFUSED 2ND OPINION, WENT TO BAYLOR TO REMOVE HAND, R+R PLATE 4 SCREWS TRASH DEBRIS LOOSE SCREWS NOT 8 / HAD VISITOR ON SURGERY RECORD, WAITED 6 HRS TO START, GRAPHOANALYSIS REFERS DR LIE ON REPORTS 4 OCCASIONS / 1 BEING PROBLEM AND EXTENT' INFORMING PT, ON PROCEDURE TO BE USED, TIGHTEN LIGAMENT, VS ARTHODESIS. REMOVE SCAPHOID, WHO DID SURGERY, THAT WAS SET WRONG, 90 OFF IDEAL, AFTER FUSION, AND RE SET. TEN DAYS LATER, THAT LIGATURE HAD OCCURRED, HEALING NICELY, STRUCK PT WHEN SHOULDER PAIN WAS REFERRED TO HIM BY THERAPIST FOOT PAIN AT NOISE." IN EARLY 2005, ENTERED THERAPY, CLEANSED FOR WEEK, THEN EXERCISES TO NO AVAIL 8 MONTH. DATES OF USE: 2004 - 2005, 12 MONTHS. DIAGNOSIS OR REASON FOR USE: CARPAL INSTABILITY, SURGICAL DRESSING, CAST. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ACE/GAUZE CADT PLASTER ACE/GAUZE CADT PLASTER LGF
2 SPIDER PLATE AND ACCESSORIES SPIDER PLATE AND ACCESSORIES HRS
3 4 PAIR 10, 12, 14 SCREWS 4 PAIR 10, 12, 14 SCREWS HWC

Patients

Seq Age Sex Outcome Treatment
1 58 YR Required Intervention| S