FDA Adverse Event
Injury
Summary report: N
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
MDR report key: 6526812
·
Received April 27, 2017
Report
- Report Number
- 3002807615-2017-00002
- Event Type
- Injury
- Date Received
- April 27, 2017
- Date of Event
- March 28, 2017
- Report Date
- April 27, 2017
- Manufacturer
- TEVA MEDICAL LTD., MIGADA SITE
- Product Code
- ONB
- PMA / PMN Number
- K141448
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
SPONTANEOUS, CONSUMER, SERIOUS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307460 | TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | ONB | TEVA MEDICAL LTD., MIGADA SITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |