FDA Adverse Event
Other
Summary report: N
J.P. [T WOUND] DRAIN
MDR report key: 538564
·
Received April 19, 2004
Report
- Report Number
- 538564
- Event Type
- Other
- Date Received
- April 19, 2004
- Date of Event
- December 1, 2003
- Report Date
- December 1, 2003
- Manufacturer
- CARDINAL [HEALTH MEDICAL PRODUCTS SERVICES]
- Product Code
- FCN
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RN [REGISTERED NURSE] MET RESISTANCE WHEN PULLING PT'S JP DRAIN. CONTACTED ATTENDING PHYSICIAN TO SEE PT. SUTURES WERE CUT AND THE M.D. [MEDICAL DOCTOR] PULLED ON THE DRAIN. THERE WAS A POP AND OUT CAME PART OF THE DRAIN. KUB [KIDNEY URETER AND BLADDER] SHOWED RETAINED DRAIN. RETURNED TO O.R [OPERATING ROOM] TO HAVE IT REMOVED. IT WAS DISCOVERED IN SURGERY THAT PART OF THE DRAIN MAY HAVE BEEN SEWN, THUS THE RESISTANCE IN INITIALLY PULLING THE DRAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J.P. [T WOUND] DRAIN | DRAIN | FCN | CARDINAL [HEALTH MEDICAL PRODUCTS SERVICES] | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |