FDA Adverse Event
Injury
Summary report: N
SYMPHONY PUMP (UNKNOWN)
MDR report key: 12780952
·
Received November 9, 2021
Report
- Report Number
- 1419937-2021-00102
- Event Type
- Injury
- Date Received
- November 9, 2021
- Date of Event
- August 4, 2021
- Manufacturer
- MEDELA AG
- Product Code
- HGX
- PMA / PMN Number
- K020518
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
CUSTOMER SERVICE REFERRED THE CUSTOMER TO HER DOCTOR. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION.
Description of Event or Problem · 0
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT WHILE IN THE HOSPITAL BETWEEN (B)(6) AND (B)(6) THAT SHE DEVELOPED HEPATITIS C AFTER HAVING A C SECTION AND USING A SYMPHONY BREAST PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1675585 | SYMPHONY PUMP (UNKNOWN) | PUMP, BREAST, POWERED | HGX | MEDELA AG | SYMPHONY PUMP (UNKNOWN) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |