MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-18 for MODIFIED HAM'S F-10 WITH ALBUMIN 99109 manufactured by Irvine Scientific.
[5226221]
Irvine scientific received a call from dr. (b)(6) , allergist, on (b)(6) 2014 from the (b)(6). He stated that he recently had an appointment with a pt who explained to him she had experienced an allergic reaction after an ivf procedure. He did not specify the ivf procedure that was performed but the pt reported that modified ham's f-10 with albumin, catalog #99109 was used in her procedure. Modified ham's f10 with albumin contains therapeutic grade injectable human serum albumin. Dr. (b)(6) provided the name of the doctor that performed the ivf procedure, dr. (b)(6), and the name of the facility where the ivf procedure took place, (b)(6). Dr. (b)(6) was not aware of the date that the ivf procedure took place and when the allergic reaction occurred. Dr. (b)(6) contacted irvine scientific as he was unsure of the reason for the pt's allergic reaction however, as the pt was told by dr. (b)(6) that our product, modified ham's f-10 with albumin, catalog #99109, was used in her procedure.
Patient Sequence No: 1, Text Type: D, B5
[12498833]
The user facility ((b)(6) ) did not report an allergic event to irvine scientific. Irvine scientific was made aware of the event by dr. (b)(6), the pt's allergist, at (b)(6). The pt told dr. (b)(6) that she underwent the ivf procedure at (b)(6) med ctr and that it was performed by dr. (b)(6). Upon investigation irvine scientific confirmed the (b)(6) med ctr is a customer however, does not have any record going as far back as 2010 of distributing modified ham's f-10 with albumin, catalog #99109 to this facility. We attempted on three (3) different occasions to contact dr. (b)(6) by phone at (b)(6) ctr and we did not receive a return call to confirm the allergic event. In addition, an internet search for dr. (b)(6) identified him as being affiliated with (b)(6) whom we contacted. (b)(6), dir of clinical operations at (b)(6) returned our call. According to ms. (b)(6) there were no reports of an allergic event for their facility. Ms. (b)(6) confirmed that dr (b)(6) visits (b)(6) med ctr approximately two (2) times per month for the intake of new ivf pts and is also responsible to perform their ultrasounds and does not perform ivp procedures at (b)(6) med ctr. Nr- not reported; is - irvine scientific. The user facility ((b)(6) med ctr) did not report the event to is. Based upon our investigation irvine scientific is not able to confirm that an allergic event occurred as a result of the use of the reported product. Modified ham's f10 with albumin contains therapeutic grade injectable human serum albumin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-2014-00001 |
| MDR Report Key | 4265607 |
| Report Source | 05 |
| Date Received | 2014-11-18 |
| Date of Report | 2014-11-08 |
| Date Mfgr Received | 2014-10-22 |
| Date Added to Maude | 2014-11-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 9492617800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODIFIED HAM'S F-10 WITH ALBUMIN |
| Generic Name | MODIFIED HAM'S F-10 WITH ALBUMIN |
| Product Code | HDR |
| Date Received | 2014-11-18 |
| Model Number | NA |
| Catalog Number | 99109 |
| Lot Number | NR |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE SCIENTIFIC |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-18 |