FDA Adverse Event
Injury
Summary report: N
IMPRESS/PK UNKNOWN
MDR report key: 112418
·
Received August 11, 1997
Report
- Report Number
- 1224675-1997-00043
- Event Type
- Injury
- Date Received
- August 11, 1997
- Date of Event
- July 23, 1997
- Report Date
- July 28, 1997
- Manufacturer
- UROMED CORP.
- Product Code
- MNG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT REPORTED DEVICE MIGRATED INTO HER VAGINA. DEVICE REMOVED BY MEDICAL PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPRESS/PK UNKNOWN | IMPRESS SOFTPATCH | MNG | UROMED CORP. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |