K-Y WARMING LIQUID
Received Apr 1, 2005 · Event occurred Jan 14, 2005
Report 2214133-2005-00002 · MDR key 588007
Device
Generic name
Personal Lubricant
Manufacturer
Personal Products Co.Model number
NACatalog number
NA
Lot number
3583C
Product problems
- Unknown (for use when the device problem is not known)
Patient
51 YR
- Swelling
- Urinary Retention
- Burning Sensation
- Surgical procedure
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
CONSUMER EXPERIENCED EXTERNAL VAGINAL BURNING AFTER USE IN 2005. THE NEXT DAY, WHEN CUNSUMER WOKE UP. CONSUMER WAS UNABLE TO URINATE. CONSUMER WENT TO THE EMERGENCY ROOM SIX DAYS LATER AND RECEIVED TREATMENT WHICH INCLUDED ANTIBIOTIC THERAPY AND INSERTION OF A FOLEY CATHETER. ONE MONTH LATER, CONSUMER CALLED TO STATE THAT CUNSUMER'S PHYSICIAN PRESCRIBED LEVAQUIN AND PYRIDIUM AND CUNSUMER WAS SCHEDULED TO SEE ANOTHER UROLOGIST TWO WEEKS LATER. CONSUMER CALLED AGAIN EIGHT DAYS EARLIER TO STATE CONSUMER SAW A UROLOGIST ON MONDAY AND CONSUMER IS SCHEDULED FOR BLADDER SURGERY THIS COMING MONDAY. CONSUMER CALLED AGAIN TO STATE CONSUMER COULD NOT HAVE THE SURGERY AND WAS RESCHEDULED THREE DAYS LATER. CUSTOMER HAD SURGERY FOR PLACEMENT OF "STENT FROM KIDNEY ON DOWN" AND IT WAS "DONE ECONOMICALLY, NOT IN OVERNIGHT". THE PHYSICIAN GAVE 5 LEVAQUIN TABLETS ALONG WITH DETROL AND PYRIDIUM. CONSUMER WAS UNABLE TO URINATE BECAUSE CONSUMER WAS SO SWOLLEN. CONSUMER WAS HAVING "BACKFLOW" AND HAD FLUID AROUND CONSUMER'S HEART AND MAY NEED FURTHER HEART SONOGRAMS. IN 2005 CONTACT WAS UPGRADED TO A GRADE 3.
Description of Event or Problem
FOLLOW UP NOTES RECEIVED FROM NORTH TEXAS SURGERY CENTER STATED THAT CONSUMER HAD A BILATERAL RETROGRADE PYELOGRAM DONE ON 03/14/05. THE RESULTS DEMONSTRATED SOME STONES PRESENT IN THE RIGHT DISTAL URETER AND A J-STENT WAS INSERTED. POST OPERATIVE DIAGNOSES WAS RIGHT URETERAL LITHIASIS AND URETHRAL STRICTURE.
Description of Event or Problem
FOLLOW UP NOTES RCEIVD FOR EMERGENCY ROOM (ER) IN 2005 STATED THAT CONSUMER COMPLAINED OF ABDOMINAL PAIN AND WEAKNESS IN THE ER AND WAS GIVEN A DIAGNOSIS OF URINARY RETENTION WITH DIFFERENTIAL DIAGNOSIS OF BLADDER SPASMS, URINARY TRACT INFECTION, RENAL FAILURE AND UNLIKELY SPINAL PATHOLOGY. FOLEY CATHETER WAS INSERTED AND DRAINED 500CC OF CLEAR URINE. CONSUMER TRATED WITH ALEVE TWO HOURS PRIOR TO ER VISIT, AND LASIX 10MG. IV INSERTED AND CAPPED. CONSUMER GIVEN A PRESCRIPTIO FOR BACTRIM DS 1 TABLET TWICE A DAY FOR FIFTEEN DAYS. VITAL SIGNS TAKEN THREE TIMES IN ER AND NORMAL THROUGHOUT THE VISIT. OXYGEN SATURATION 98%. RECORDS RECEIVED FROM UROLOGIST FROM 2005 AND AFTER EXAM CONSUMER COMPLAINED OF BACK PAIN. PHYSICIAN STATES IT COULD BE DUE TO BEING ON EXAM TABLE WITH LEGS IN STIRRUP. CONSUMER SELF-TREATED WITH ALEVE. FOLEY CATHETER REMAINS IN PLACE. IN 2005 CONSUMER WAS SEEN BY UROLOGIST AND STILL COMPLAINED OF BACK PAIN. SONOGRAM WAS DONE AND SHOWED 14.5CC URINE RESIDUAL. FOLEY DISCONTINUED AT HIS TIME AND CONSUMER VOIDING WITHOUT ANY DIFFICULTIES. THREE DAYS LATER CONSUMER SAW UROLOGIST AND COMPLAINED OF DIFFICULTY URINATING. CONSUMER WAS STRAIGHT CATHERIZED WITH A RESIDUAL URINE OF 40CC AND URINALYSIS DONE WITH TRACE BLOOD, 10MG/DL OF PROTEIN, MODERATE BILIRUBIN, 5MG/DL OF PROTEIN, MODERATE BILIRUBIN, 5MG/DL OF KETONES. CONSUMER PRESCRIBED DETROL LA FOR 10 DAYS AND LEVBID 250MG. TWO DAYS LATER CONSUMER SAW FAMILY PHYSICIAN AND WAS DIAGNOSED WITH URINARY TRACT INFECTION, URINARY RETENTION, DYSURIA A ND CHRONIC ANXIETY. VITAL SIGNS NORMAL. URINALYSIS SHOWED POSITIVE NITRATES, TRACE PROTEIN AND 3-BILIRUBIN. REFERRAL GIVEN TO ANOTHR UROLOGIST. TWENTYONE DAYS LATER CONSUMER WAS SEEN AGAIN BY FAMILY PHYSICIAN AND COMPLAINED OF SUPRAPUBIC TENDERNESS. CONSUMER TAKING PHENAZYPRYDINE AND VITAL SIGNS NORMAL. URINALYSIS SHOWED TRACE LEUKOCYTES IN ADDITION TO PREVIOUS RESULTS. SEVERAL ATTEMPTS MADE TO REQUEST MED RECORDS FROM PHYSICIAN WHO PERFORMED PROCEDURES. NO INFO RECEIVED TO DATE.