MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-06-11 for CRYOTIP 40709 manufactured by Irvine Scientific.
[21757636]
Customer is located in china and reported to the irvine scientific's distributor in china that an end user obtained a "little laceration" on his face when thawing specimens contained in the device.
Patient Sequence No: 1, Text Type: D, B5
[21927857]
It is not clear from the little info that has been provided by the user if a serious injury occurred. Irvine scientific will file a medical device report in an abundance of caution. Customer is located in (b)(6) and reported to irvine scientific's distributor in (b)(4) that an end user obtained a "little laceration" on his face when thawing specimens contained in the device. Details with regards to the product lot number and a description of the injury have not been provided after several requests. Irvine scientific has diligently requested details with regards to the injury that was sustained and the product specific lot number and had not been successful and is filing this report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-2012-00001 |
| MDR Report Key | 2625838 |
| Report Source | 01 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-06-11 |
| Date of Event | 2012-05-07 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-08-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | CRYOTIP |
| Product Code | MQH |
| Date Received | 2012-06-11 |
| Model Number | NA |
| Catalog Number | 40709 |
| Lot Number | PENDING |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-06-11 |