FDA Adverse Event
Injury
Summary report: N
VUMORE SPECULUM
MDR report key: 31325
·
Received March 19, 1996
Report
- Report Number
- MW1008675
- Event Type
- Injury
- Date Received
- March 19, 1996
- Date of Event
- January 31, 1996
- Report Date
- March 13, 1996
- Manufacturer
- MEDICAL ENGINEERING CO.
- Product Code
- HDG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
MEDICAL ENGINEERING CORP. 2317 EATON LANE, RACINE, WI 53404. THIS PRODUCT WAS NEVER MFG BY THE COOPER SURGICAL SUBSIDIARY PURCHASED BY MEDICAL ENGINEERING CORP, NOR WAS IT EVER MFG BY MEDICAL ENGINEERING CORP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VUMORE SPECULUM | SPECULUM | HDG | MEDICAL ENGINEERING CO. | 6106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Hospitalization| R |