FDA Adverse Event
Injury
Summary report: N
MOSIE BABY
MDR report key: 16919504
·
Received May 11, 2023
Report
- Report Number
- MW5117483
- Event Type
- Injury
- Date Received
- May 11, 2023
- Date of Event
- November 1, 2022
- Report Date
- May 22, 2023
- Manufacturer
- MOSIE, INC.
- Product Code
- KYZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5117483 FOR PROCODE KYZ AND MANUFACTURER MOSIE INC.
Description of Event or Problem · 0
HUSBAND AND I USED THIS INSTEAD OF SEX TO MAKE OUR BABY AND I WAS LEFT WITH PELVIC INFLAMED DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1356263 | MOSIE BABY | SYRINGE, IRRIGATING (NON DENTAL) | KYZ | MOSIE, INC. | |||
| 650425 | MOSIE BABY | SYRINGE, IRRIGATING (NON DENTAL) | KYZ | MOSIE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention | MOSIE BABY. |