MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 1997-02-10 for MODIFIED SPERM WASHING MEDIUM 9984 manufactured by Irvine Scientific.
[44728]
0n friday, 1/10/97, co received notification from a physician at clinic stating a pt that had undergone an intrauterine insemination (iui) procedure on 12/13/96, had experienced a reaction. Co was contacted on friday, 1/10/97, regarding this customer notification. The date of the event was friday, 12/13/96. Co did not receive complete info regarding product lot number of other identification. On 1/15/97 the product lot number was obtained from the customer. On 12/13/96, the pt presented the day after her lh surge for an intrauterine insemination. Standard wash was done twice with a swim up and the supernatant from the swim up had a count of 65 million per mil, 89% motile sperm and was drawn up in a tomcat catheter and intrauterine insemination was done with the swim up sperm. The pellet was placed in the cervix, again with a tomcat catheter. Immediately after the insemination, the speculum was removed and the pt began feeling severe cramping and then became nauseated. Vital signs remain stable, but because of continued cramping and nausea, she was given some smelling salts and 400 milligrams of motrin. Within five minutes after the motrin, the pt developed diffuse hives and swelling. Throughout this entire time, her lung sounds were clear. At this point, she was given sub-cutaneous epinephrine as well as intramuscular benadryl and was then taken by ambulance to hosp, where she was given solu-medrol and observed overnight. She never developed respiratory distress. Of interest is that the pt has a history of asthma, more severe as a child, mild as an adult and a history of multiple allergies to penicillin, sulfa drugs, tetanus, peanuts, pollen and msg, all of which cause full body swelling. It is unclear exactly what she was reacting to. Reports of true allergy to sperm are extremely rare. It may be possible that the pt was allergic to the bovine serum albumin used in the media.
Patient Sequence No: 1, Text Type: D, B5
[7765242]
The raw materials used to mfr lot #998460823 were reviewed and found to meet all in-coming raw material specifications. The device history record for the product was reviewed and found to meet all finished product specifications. The lot was mfg according to the mfg protocal and no deviations occurred during the mfg process. No other complaints of this nature have been received on this lot of product. This is the final follow up rpt for this mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-1997-00001 |
| MDR Report Key | 68757 |
| Report Source | 04,05,06 |
| Date Received | 1997-02-10 |
| Date of Report | 1997-02-10 |
| Date of Event | 1996-12-13 |
| Date Mfgr Received | 1997-01-10 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1997-02-19 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODIFIED SPERM WASHING MEDIUM |
| Generic Name | SPERM WASHING PROCEDURES |
| Product Code | HDR |
| Date Received | 1997-02-10 |
| Model Number | NA |
| Catalog Number | 9984 |
| Lot Number | 99840823 |
| ID Number | NA |
| Device Expiration Date | 1998-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 68721 |
| Manufacturer | IRVINE SCIENTIFIC |
| Manufacturer Address | 2511 DAIMLER ST. SANTA ANA CA 927055588 US |
| Baseline Brand Name | MODIFIED SPERM WASHING MEDIUM |
| Baseline Model No | NA |
| Baseline Catalog No | 9984 |
| Baseline ID | * |
| Baseline Device Family | CERVICAL CAP |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K874668 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-10 |