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.
[17801452]
Pt underwent intrauterine insemination (iui) at fertility clinic using sperm treated with irvine scientific's sperm wash medium, lot 998390402. Report states that pt subsequently experienced fever of 100. 2 degrees, chills, elevated white blood count and abdominal cramping. Pt was treated with oral vibramycin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022379-1999-00001 |
| MDR Report Key | 250558 |
| Report Source | 05,06 |
| Date Received | 1999-11-18 |
| Date of Report | 1999-11-18 |
| Date of Event | 1999-10-10 |
| 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 | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPERM WASHING MEDIUM |
| Generic Name | SPERM PROCESSING MEDIA |
| 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 | 242745 |
| 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. Required No Informationntervention | 1999-11-18 |