MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-18 for SPERM WASHING MEDIUM 9983 manufactured by Irvine Scientific.
[161021]
Pt underwent intrauterine insemination (iui) at fertility clinic using sperm treated with irvine scientific's sperm wash medium, lot number 998390402. Report states pt experienced pelvic inflammatory disease (pid) and right hydrosalpinx after iui. Pt was admitted to hosp and treated with iv antibiotics. Pt has since been discharged with continued treatment on iv antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022379-1999-00002 |
| MDR Report Key | 250513 |
| Report Source | 05,06 |
| Date Received | 1999-11-18 |
| Date of Report | 1999-11-18 |
| Date of Event | 1999-10-20 |
| Date Mfgr Received | 1999-10-22 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 1999-11-22 |
| 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 |
| Manufacturer Contact | ROBERTA JOHNSON |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 8004375706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPERM WASHING MEDIUM |
| Generic Name | SPERM PROCESSING MEDIUM |
| Product Code | MQL |
| Date Received | 1999-11-18 |
| Returned To Mfg | 1999-10-28 |
| Model Number | NA |
| Catalog Number | 9983 |
| Lot Number | 998390204 |
| ID Number | NA |
| Device Expiration Date | 2001-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 242704 |
| Manufacturer | IRVINE SCIENTIFIC |
| Manufacturer Address | 2511 DAIMLER ST. SANTA ANA CA 92705 US |
| Baseline Brand Name | SPERM WASHING MEDIUM |
| Baseline Generic Name | SPERM PROCESSING MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | 9983 |
| Baseline ID | NA |
| Baseline Device Family | SPERM WASHING MEDIA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K983588 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Hospitalization; 2. Required No Informationntervention | 1999-11-18 |