FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 1210871 · Received October 22, 2008

Report

Report Number
MW5008728
Event Type
Injury
Date Received
October 22, 2008
Date of Event
June 10, 2004
Report Date
October 12, 2008
Manufacturer
UNK
Product Code
FTL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

MY MOTHER HAD A SURGERY TO REPAIR PROLAPSED BLADDER AT THE HOSPITAL IN 2004. A STANDARD SURGICAL MESH WAS USED - MOST LIKELY THE TYPE FDA WARNED ABOUT TODAY. THE SURGERY WAS FOLLOWED BY EXCRUCIATING PAIN AND SUSTAINED INTERNAL BLEEDING - WHICH WAS DISCOVERED ONLY ABOUT A WEEK LATER - BY ACCIDENT - BY WHICH TIME MY MOTHER DEVELOPED A MASSIVE 6-INCH HEMATOMA IN DIAMETER, WHICH COMPLETELY BLOCKED THE LEFT URETER AND OBSTRUCTED THE LEFT KIDNEY, AS WELL AS SIGNIFICANTLY IMPAIRED THE FUNCTION OF THE LEFT URETER. AN EMERGENCY KIDNEY CATHETERIZATION WAS REQUIRED IN ORDER TO UNBLOCK LEFT KIDNEY AND ALLOW THE ACCUMULATED URINE TO BE DISCHARGED, AND TO PREVENT NECROSIS OF THE KIDNEY. THE KIDNEY CATHETERIZATION WAS BRUTALLY PAINFUL AND TRAUMATIC AND WAS FOLLOWED BY, NOT WEEKS BUT MONTHS, OF DAY-AND-NIGHT FEVER WHICH NEVER DROPPED BELOW 37.5C AND WHICH AT TIMES REACHED 40C. MY MOTHER HAD AN UNINTERRUPTED HIGH FEVER FOR AT LEAST TWO SOLID, CONTINUOUS MONTHS - PERHAPS AS LONG AS THREE - AND ALMOST DID NOT SURVIVE. WE STRONGLY SUSPECT THAT THE 3-MONTH FEVER CAUSED MY MOTHER'S SEVERE ANEMIA AND CONTRIBUTED TO THE ONSET OF SUSPECTED - MYELODYSPLASTIC SYNDROME - MDS, FOR WHICH SHE IS CURRENTLY BEING MONITORED AT SLOAN-KETTERING MEMORIAL HOSPITAL CENTER IN NEW YORK - IMMEDIATELY PRIOR TO THE BLADDER REPAIR SURGERY IN 2004, MY MOTHER'S PLATELET COUNT WAS AROUND 250,000; TWO MONTHS AFTER THE SURGERY, IT DROPPED TO ABOUT 80,000 WHERE IT STILL IS AS OF TODAY, IN 2008. EXACTLY A YEAR AFTER THE BLADDER REPAIR SURGERY, MY MOTHER REQUIRED A RADICAL HYSTERECTOMY FOR UNEXPLAINED AND ATYPICAL BLEEDING FROM THE UTERUS AND SIGNIFICANT COMPROMISING CHANGES ON THE INNER LINING OF THE UTERUS - ALMOST CERTAINLY CAUSED BY THE SURGICAL MESH WHICH PROBABLY PENETRATED THROUGH THE WALL OF THE UTERUS. THE HYSTERECTOMY WENT WITHOUT A HITCH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN UNK FTL UNK UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 69 YR Hospitalization| L| O| S