MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-04-01 for K-Y WARMING LIQUID manufactured by Personal Products Co..
[368569]
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.
Patient Sequence No: 1, Text Type: D, B5
[423601]
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.
Patient Sequence No: 1, Text Type: D, B5
[22172876]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2005-00002 |
| MDR Report Key | 588007 |
| Report Source | 04 |
| Date Received | 2005-04-01 |
| Date of Report | 2005-03-31 |
| Date of Event | 2005-01-14 |
| Date Mfgr Received | 2005-02-07 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2005-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088741402 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y WARMING LIQUID |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | MMS |
| Date Received | 2005-04-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 3583C |
| ID Number | NA |
| Device Expiration Date | 2005-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 577849 |
| Manufacturer | PERSONAL PRODUCTS CO. |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-01 |