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 2017-08-28 for API? NIN-2 70491 manufactured by Biomerieux, Sa.
[83834662]
A customer from (b)(6) reported to biom? Rieux exposure to reagent liquid due to leakage of api? Nin-2. The customer reported that their fingers turned purple when opening the box, and that the bottom right hand corner of the white box was brownish in color. The customer did not use the product. There is no indication or report from the customer that the exposure led to any adverse event related to the user's state of health. Biom? Rieux requested additional information from the customer as api? Nin-2 is toxic when in contact with skin. There has been no response from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00252 |
| MDR Report Key | 6824790 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-28 |
| Date of Report | 2017-10-18 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2017-08-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API? NIN-2 |
| Generic Name | API? NIN-2 |
| Product Code | JTO |
| Date Received | 2017-08-28 |
| Catalog Number | 70491 |
| Lot Number | 1005510500 |
| ID Number | 03573026141974 |
| Device Expiration Date | 2018-02-21 |
| 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, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-28 |