UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-02 for UNKNOWN manufactured by William A. Cook Australia, Pty Ltd.

Event Text Entries

[173459376] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9680654-2020-00001
• MDR Report Key: 9540871
• Report Source: LITERATURE
• Date Received: 2020-01-02
• Date of Report: 2020-02-18
• Date of Event: 2019-12-02
• Date Mfgr Received: 2019-12-04
• Date Added to Maude: 2020-01-02
• 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: 3
• Manufacturer Contact: MR NICOLAS BIDAUD
• Manufacturer Street: 95 BRANDL STREET EIGHT MILE PLAINS
• Manufacturer City: BRISBANE QLD 4113
• Manufacturer Country: AS
• Manufacturer Postal: QLD 4113
• Manufacturer Phone: 738411188
• Manufacturer G1: WILLIAM A. COOK AUSTRALIA, PTY LTD
• Manufacturer Street: 95 BRANDL STREET EIGHT MILE PLAINS
• Manufacturer City: BRISBANE QLD 4113
• Manufacturer Country: AS
• Manufacturer Postal Code: QLD 4113
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN
• Generic Name: MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES
• Product Code: MQE
• Date Received: 2020-01-02
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WILLIAM A. COOK AUSTRALIA, PTY LTD
• Manufacturer Address: 95 BRANDL STREET EIGHT MILE PLAINS BRISBANE QLD 4113 AS QLD 4113

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-02