ISOLATE SPERM SEPARATION MEDIA * 99258

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 1998-03-10 for ISOLATE SPERM SEPARATION MEDIA * 99258 manufactured by Irvine Scientific.

Event Text Entries

[94388] Infection post intra-uterine insemination. A pt who had undergone intra-uterine insemination on 2/5/98, developed pain on 2/6/98. She was admitted emergently in-pt due to severe pain. Blood testing included wbc. Observed 12 hrs with pain worsening, she was treated with an antibiotic iv. Pain improved over 48 hrs but persitent elevated white count with persistent increased bands. On 2/9/98, the user facility became aware that an isolate used in the iui was recalled because some units in the affected lot were not sterile. The distributor put the user facility in direct contact with the mfr to learn the identity of the contaminants identified. They were informed that the contaminants were two fungi, one identified as aureobasidium pullulans and the other as an ascomycete. The treating physician sought a consultative eval by an infectious disease dr. On 2/12/98, the mfr conducted a follow-up phone call with the user facility and learned that the treating physician had determined that the pt's condition was not due to fungus. The pt had a previous hydrosalpinx that led to infection following the iui procedure. The pt had been released from the hosp and was continuing on iv-antibiotic therapy for 2 weeks. The unit involved had already been destroyed. No visible sign of contamination had been present. On 2/25/98, the mfr again conducted a follow-up phone call to determined if there was any new info about the problem. The user facility confirmed that the treating physician diagnosed that a pre-existing infection and hydrosalpinx had been re-activated by the iui procedure. The treating physician concluded that there was no connection of the event with the use of the recalled product. The user facility was requested to provide details to help document the case and to complete investigation for possible mdr. On 3/4/98, add'l info obtained included identificatin of iv-antibiotics used (ampicillin, gentamycin and cleocin). The pt was finishing antibiotics and was being scheduled for future salpingectomy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2022379-1998-00001
• MDR Report Key: 155189
• Report Source: 05,06,08
• Date Received: 1998-03-10
• Date of Report: 1998-02-09
• Date of Event: 1998-02-06
• Date Mfgr Received: 1998-02-09
• Device Manufacturer Date: 1997-09-01
• Date Added to Maude: 1998-03-12
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Removal Correction Number: 2-315-8
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ISOLATE SPERM SEPARATION MEDIA
• Generic Name: HUMAN SPERM SEPARATION MEDIUM FOR INTRA-UTERINE INSEMINATION
• Product Code: MQL
• Date Received: 1998-03-10
• Model Number: *
• Catalog Number: 99258
• Lot Number: 9925870911
• ID Number: *
• Device Expiration Date: 1999-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 151166
• Manufacturer: IRVINE SCIENTIFIC
• Manufacturer Address: 2511 DAIMLER ST. SANTA ANA CA 92705 US
• Baseline Brand Name: ISOLATE SPERM SEPARATION MEDIA
• Baseline Generic Name: HIMAN SPERM SEPARATION MEDIA
• Baseline Model No: NA
• Baseline Catalog No: 99258
• Baseline ID: NA
• Baseline Device Family: SPERM SEAPATATION MEDIA
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 24
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K971809
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1998-03-10