FDA Adverse Event
Injury
Summary report: N
DELTEC (SIMS DELTEC INC)
MDR report key: 410296
·
Received August 6, 2002
Report
- Report Number
- 410296
- Event Type
- Injury
- Date Received
- August 6, 2002
- Date of Event
- July 2, 2002
- Report Date
- July 9, 2002
- Manufacturer
- SIMS DELTEC INC
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT. WAS 3 WHEELING AND HIT SOME BUMPS AND HURT RIGHT SIDE. THE PT FELT SOMETHING "RIP". STUDY YESTERDAY SHOWED CATHETER TO BE DISRUPTED AT ILIAC CREST. PERITONEAL PORTACATH REPLACED ON THE DAY OF THE EVENT TO CONTINUE CHEMO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTEC (SIMS DELTEC INC) | PERITONEAL PORT-A-CATH | LJT | SIMS DELTEC INC | 21-2000 | L72790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization | CHEMO FOR OVARIAN CA. |