MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-30 for VITEK 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc..
[143565750]
A customer in (b)(6) notified biom? Rieux of employee injuries in association with the use of vitek? 2 gn test kit (reference 21341, lot 2410770203). This high throughput customer opens approximately 400 card pouches a per day and has stated that the pouches have become difficult to open and resulted in employee injuries. Specifically, the customer alleged they have had two employees out for four weeks for seven weeks of work respectively of work (for four weeks and seven weeks, respectively) due to forearm injuries that required splints. The customer confirmed that they were tearing the pouches open using the notches in the packaging per the instructions for use but are now using scissors to open the pouches. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2019-00110 |
| MDR Report Key | 8565229 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-30 |
| Date of Report | 2019-07-18 |
| Date Mfgr Received | 2019-06-20 |
| Date Added to Maude | 2019-04-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK 2 GN TEST KIT |
| Generic Name | VITEK 2 GN TEST KIT |
| Product Code | LQM |
| Date Received | 2019-04-30 |
| Catalog Number | 21341 |
| Lot Number | 2410770203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-30 |