FDA Adverse Event
Other
Summary report: N
PHARMACIA DELTEC
MDR report key: 45069
·
Received October 22, 1996
Report
- Report Number
- 45069
- Event Type
- Other
- Date Received
- October 22, 1996
- Date of Event
- August 26, 1996
- Report Date
- September 11, 1996
- Manufacturer
- SMITHS INDUSTRIES
- Product Code
- MDV
- Report Source
- User Facility report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
DX: RSD RIGHT HAND. PT HAD IMPLANT OF EPIDURAL CATHETER ON 5/6/96-LEVEL C2. PT WAS PLACED ON A CONTINUOUS INFUSION ON 6/10/96. PT HAD INFUSION WITH 1/8% MARCAINE FOR APPROX. 4 WKS. PT EXPERIENCED SOME INFLAMMATION ABOVE PORT, TENDERNESS AT PORT SITE. INCREASED PAIN WITH ACTIVITY. PORT WAS REMOVED 8/26/96 DUE TO POSSIBLE INFECTION AT PORT SITE. SMALL AMOUNT OF PUS SUBCUTANEOUSLY JUST SUPERFICIAL TO THE RESERVOIR. PT WAS AFEBRILE. PT HAS BEEN ON AUGMENTIN 500MG. TID FOR 10 DAYS. THE INFECTION WAS NOT RELATED TO PORT OR POCKET. (NOT CAUSED)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHARMACIA DELTEC Implant | EPIDUARL PORT-A-CATH | MDV | SMITHS INDUSTRIES | 21-0501 | 22441A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other |