FDA Adverse Event
Injury
Summary report: N
DATARECORDER 2 (JP)
MDR report key: 5189008
·
Received October 29, 2015
Report
- Report Number
- 9710107-2015-05015
- Event Type
- Injury
- Date Received
- October 29, 2015
- Date of Event
- September 18, 2015
- Report Date
- October 1, 2015
- Manufacturer
- GIVEN LTD (ISRAEL)
- Product Code
- NEZ
- PMA / PMN Number
- K101250
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT ASPIRATED SB2 CAPSULE. THE CAPSULE WAS RELEASED BY COUGHING. IT WAS REPORTED NO HARM TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719740 | DATARECORDER 2 (JP) | DR2 | NEZ | GIVEN LTD (ISRAEL) | FGS-0193-J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |