MAUDE MDR 9540871

MDR report key
9540871
Report number
9680654-2020-00001
Event key
0
Event type
3
Date of event
2019-12-02
Date received
2020-01-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR NICOLAS BIDAUD
Address
95 BRANDL STREET EIGHT MILE PLAINS BRISBANE QLD 4 AS
Phone
738-738-7384
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWNMQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLESWILLIAM A. COOK AUSTRALIA, PTY LTDMQEUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0201. R

Event Narratives#

D

Patient 1

A (B)(6)-YEAR-OLD WOMAN PRESENTED TO THE ER 4 H AFTER TRANSVAGINAL OOCYTE RETRIEVAL (TVOR) WITH ACUTE HEMATURIA AND WORSENING SUPRAPUBIC PAIN. SHE HAD OVULATORY INFERTILITY DUE TO POLYCYSTIC OVARIAN SYNDROME. IMMEDIATELY AFTER DISCHARGE, THE PATIENT REPORTED DIFFUSE LOWER ABDOMINAL PAIN, PARTICULARLY OVER SUPRAPUBIC REGION, AND DIFFICULTY IN VOIDING. HER VITAL SIGN WAS STABLE. THE PHYSICAL EXAMINATION REVEALED LOCALIZED TENDERNESS OVER LOWER ABDOMEN WITHOUT REBOUND PAIN AND A DRIBBLING URINARY STREAM WAS OBSERVED DURING MICTURITION. A TRANSVAGINAL ULTRASOUND SHOWED A SOLID MASS IN THE BLADDER (78 X 46 MM), 2 ENLARGED OVARIES (68 X 50 MM AND 71 X 61 MM), NO PELVIC FLUID, AND A NORMAL-APPEARING UTERUS. DUE TO HER SYMPTOMS OF URINARY RETENTION, HER BLADDER WAS DRAINED USING A PLASTIC CATHETER, AND HEMATURIA WAS EVIDENT. A URINALYSIS INDICATED MORE THAN 500 RED BLOOD CELLS PER HIGH-POWER FIELD. LABORATORY ANALYSIS INDICATED LEUKOCYTOSIS (WHITE BLOOD CELL COUNT: 16,200/ML), BUT HER HEMOGLOBIN AND HEMATOCRIT WERE NORMAL. SHE WAS MANAGED CONSERVATIVELY WITH AN INDWELLING THREE-WAY FOLEY CATHETER FOR IRRIGATION, AND TO DRAW AWAY CLOTS THAT OBSTRUCTIVE IN THE BLADDER. A PROPHYLACTIC ANTIBIOTIC WAS ALSO GIVEN. HOWEVER, THE BLADDER HEMATURIA PERSISTED, AND SOMETIMES EVEN CLOGGED THE CATHETER. 5 DAYS AFTER ADMISSION, THE LABORATORY EXAMINATION SHOWED DECREASED HEMOGLOBIN (FROM 12.0 G/DL TO 10.8 G/DL). TRANSVAGINAL ULTRASOUND REVEALED THE BLADDER HEMATOMA WAS STILL PRESENT COMPARED WITH THE EXAMINATION PREVIOUSLY PERFORMED (60 X 26 MM) DUE TO THE FAILURE OF CONTINUOUS IRRIGATION AND FURTHER ANEMIA, THE CYSTOSCOPY WAS PERFORMED BY THE UROGYNECOLOGIST WITH THE TEAM TO REMOVE THE CLOTS AND SEARCH FOR THE POTENTIAL BLEEDING SITE. THE CYSTOSCOPY REVEALED DENSE BLOOD CLOTS AND FOCAL ERYTHEMOUS AREA ON THE MUCOSA OF RIGHT LATERAL FLOOR. NO ACTIVE BLEEDING OR DISRUPTED MUCOSA WAS FOUND. CLOT EVACUATION WAS PERFORMED USING A CYSTOSCOPE SHEATH WITH AN ELLIK EVACUATOR, FOLLOWED BY SINGLE-BLASTOCYST TRANSFER ON THE SAME DAY. SHE REPORTED BEING COMFORTABLE, AND HAD NO FURTHER HEMATURIA AFTER THIS PROCEDURE. SHE WAS DISCHARGED 3 DAYS AFTER THE CYSTOSCOPY, AND TRANSFERRED TO A CONTINUOUS PROGESTERONE AND ESTRADIOL SUPPLEMENT.