FDA Adverse Event
Injury
Summary report: N
LORENZ PECTUS SYSTEM
MDR report key: 589492
·
Received April 7, 2005
Report
- Report Number
- 1032347-2005-00003
- Event Type
- Injury
- Date Received
- April 7, 2005
- Report Date
- February 14, 2005
- Manufacturer
- WALTER LORENZ SURGICAL, INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT COMPLICATIONS FOLLOWING PECTUS PROCEDURE PROVIDED THROUGH A COPY OF A WEB SITE COMMUNICATION. USER FACILITY INVESTIGATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LORENZ PECTUS SYSTEM | SUPPORT BAR | HRS | WALTER LORENZ SURGICAL, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| L| R |