MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for LANTUS INSULIN PEN 40 UNITS manufactured by Sanofi-aventis U.s. Llc.
[183739226]
Reporter said her insulin pen button does not click, it does not go down as if it is stuck. Reporter said she received 3 boxes that contain 5 per box. Out of the 15 pens only 3 of them worked.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5093719 |
MDR Report Key | 9828912 |
Date Received | 2020-03-12 |
Date of Report | 2020-03-12 |
Date of Event | 2020-03-11 |
Date Added to Maude | 2020-03-13 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | PATIENT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 4 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 5 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 6 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 7 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 8 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 9 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 10 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 11 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Brand Name | LANTUS INSULIN PEN 40 UNITS |
Generic Name | INJECTOR, PEN |
Product Code | NSC |
Date Received | 2020-03-12 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 12 |
Device Event Key | 0 |
Manufacturer | SANOFI-AVENTIS U.S. LLC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-12 |