MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-12-02 for SUREFIL 6% SEQUENCING GEL CARTRIDGE 06635553 manufactured by Amresco Inc..
[1020558]
An operator was injecting the contents of a surefil 6% sequencing gel cartridge into a microcell electrophoresis cassette. The cartridge failed under pressure and the acrylamide in the cartridge splashed onto the face of the operator, exposing the operator to a neurotoxin. The surefil cartridge was thought to be damaged prior to use, but the damage was not visible to the operator. There has been no report of adverse health consequences as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[8131434]
The operator was following proper safety procedures and was wearing safety glasses and other personal protective equipment as directed in the product labeling. The operator was splashed in the face with the acrylamide. The labeling indicates that the product is toxic and directs the user to wash copiously with water in case of contact. The operator cleaned her skin with water immediately and consulted with the medical doctors in the laboratory. No other defective cartridges have been reported or found during inspection of samples of the lot retained by the manufacturer and newer lots in stock. For medical device reporting purposes this event is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003932969-2008-00004 |
| MDR Report Key | 1258176 |
| Report Source | 07 |
| Date Received | 2008-12-02 |
| Date of Report | 2008-11-20 |
| Date of Event | 2008-11-14 |
| Date Mfgr Received | 2008-06-11 |
| Date Added to Maude | 2010-05-08 |
| 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 Contact | SONIA STEWART |
| Manufacturer Street | 725 POTTER ST. |
| Manufacturer City | BERKELEY CA 94710 |
| Manufacturer Country | US |
| Manufacturer Postal | 94710 |
| Manufacturer Phone | 5109824068 |
| Manufacturer G1 | AMRESCO, INC. |
| Manufacturer Street | 30175 SOLON INDUSTRIAL PKWY |
| Manufacturer City | SOLON OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUREFIL 6% SEQUENCING GEL CARTRIDGE |
| Generic Name | SEQUENCING GEL CARTRIDGE |
| Product Code | MVU |
| Date Received | 2008-12-02 |
| Catalog Number | 06635553 |
| Lot Number | 1818B007 |
| ID Number | NA |
| Device Expiration Date | 2009-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMRESCO INC. |
| Manufacturer Address | 30175 SOLON INDUSTRIAL PKWY SOLON OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-02 |