FDA Adverse Event
Other
Summary report: N
SOLETRA
MDR report key: 526188
·
Received May 21, 2004
Report
- Report Number
- 6000032-2004-00653
- Event Type
- Other
- Date Received
- May 21, 2004
- Date of Event
- January 26, 2004
- Report Date
- April 2, 2004
- Manufacturer
- MEL REL, INC.
- Product Code
- MHY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED PT INFECTION WAS NOT MENINGITIS. INFECTION SIGNS AND SYMPTOMS WERE REDNESS, INCISIONAL WOUND OPENING AND A SOFT, SLIGHT PURPLE AREA. THE PRIMARY LOCATION OF THE INFECTION WAS THE SCALP. CULTURES WERE OBTAINED FROM THE SCALP WOUND AND THE TYPE OF ORGANISM FOUND WAS SERRATIA. THE PT WAS TREATED WITH IV ANTIBIOTICS AND THE TOTAL DEVICE SYSTEM WAS EXPLANTED. THE FIRST INFECTION RESOLVED AND THE SECOND INFECTION IS IN-PROGRESS. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | IPG | MHY | MEL REL, INC. | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other | LEAD MODEL 3387 LOT# J0309461V IMP:2003,| EXPLANT: UNK.| EXPLANT: UNK,| EXT MODEL 7428 LOT# NHU002475V, IMPLANT: 2003, |