FDA Adverse Event
Malfunction
Summary report: N
BODYGUARD MICROSET WITH FILTER
MDR report key: 5553848
·
Received April 4, 2016
Report
- Report Number
- MW5061528
- Event Type
- Malfunction
- Date Received
- April 4, 2016
- Date of Event
- March 31, 2016
- Report Date
- April 4, 2016
- Manufacturer
- CAESAREA MEDICAL ELECTRONICS LTD.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
BODYGUARD MICROSET WITH FILTER TUBING, REF# (B)(4), LOT: 12399124, EXP. 09/2020, APPEARED TO HAVE EXCESS MOISTURE WITHIN THE PACKAGING OF 2 TUBING SETS ON (B)(6) 2016. MOISTURE WITHIN PACKAGING IS DISSIPATED ON (B)(6) 2016. THE PRODUCT IS NOT COMPOUNDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202029 | BODYGUARD MICROSET WITH FILTER | BODYGUARD MICROSET WITH FILTER | FPA | CAESAREA MEDICAL ELECTRONICS LTD. | 12399124 | ||
| 202030 | BODYGUARD MICROSET WITH FILTER | BODYGUARD MICROSET WITH FILTER | FPA | CAESAREA MEDICAL ELECTRONICS LTD. | 12399124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |