MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-11-18 for CRYOTIP NR 40709 manufactured by Irvine Scientific.
[5224806]
Irvine scientific received a call from the above mentioned pt, on (b)(6) 2014. The pt first stated she was the customer service rep and later in the call stated she was the receptionist calling on behalf of the pt from (b)(6). The pt reported she wanted to discuss the cryotip as a client of hers had lost embryos due to microfractures. (b)(6) informed irvine scientific that the above mentioned pt was not an employee of their facility and was in fact their pt. Irvine scientific followed up with (b)(6), and they did not have any additional info to provide as they did not record an event regarding microfractures using the cryotip.
Patient Sequence No: 1, Text Type: D, B5
[12566482]
The user facility, (b)(6), did not report the event to irvine scientific. The pt called on (b)(6) 2014 stating she was an employee of (b)(6) and wanted to discuss the cryotip on behalf of a client whom she stated lost embryos due to microfractures. (b)(6) confirmed the individual was not an employee and was their pt, and confirmed that they did not have an event to report with regards to this pt. (b)(6) confirmed that the pt had been to several fertility clinics and has not become pregnant and has questioned the procedures that have been performed during the course or her treatment. (b)(6) confirmed that they did not provide any details to the pt with regards to the use of the cryotip. (b)(6) did not provide any details regarding the product lot number of the cryotip to irvine scientific. Based upon our investigation irvine scientific was not able to confirm the occurrence of the event reported by the pt when she called posing as a (b)(6) employee.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-2014-00002 |
| MDR Report Key | 4272012 |
| Report Source | 00 |
| Date Received | 2014-11-18 |
| Date of Report | 2014-11-18 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2014-11-25 |
| 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 | 1830 E WARNER |
| Manufacturer City | SANTA ANA CA 927055588 |
| Manufacturer Country | US |
| Manufacturer Postal | 927055588 |
| Manufacturer Phone | 9492617800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | CRYOTIP |
| Product Code | MQH |
| Date Received | 2014-11-18 |
| Model Number | NR |
| Catalog Number | 40709 |
| Lot Number | NR |
| ID Number | NR |
| Operator | LAY USER/PATIENT |
| 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 |