MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-17 for PEN II OMNITROPE PEN 10 47286578 manufactured by Becton Dickinson.
| Report Number | 2243072-2019-01462 |
| MDR Report Key | 8800654 |
| Date Received | 2019-07-17 |
| Date of Report | 2019-08-12 |
| Date of Event | 2019-06-09 |
| Date Mfgr Received | 2019-07-04 |
| Device Manufacturer Date | 2018-10-09 |
| Date Added to Maude | 2019-07-17 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEN II OMNITROPE PEN 10 |
| Generic Name | PEN NEEDLE |
| Product Code | NSC |
| Date Received | 2019-07-17 |
| Returned To Mfg | 2019-07-03 |
| Catalog Number | 47286578 |
| Lot Number | 18269004 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-17 |