FDA Adverse Event
Injury
Summary report: N
ROSS HIDE-A-PORT GASTROSTOMY KIT
MDR report key: 275754
·
Received April 27, 2000
Report
- Report Number
- 1528738-2000-00023
- Event Type
- Injury
- Date Received
- April 27, 2000
- Date of Event
- April 4, 2000
- Report Date
- April 19, 2000
- Manufacturer
- ROSS PRODUCTS DIV. ABBOTT LABORATORIES, INC.
- Product Code
- KNT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
PT'S MOTHER INDICATED THERE WAS REDNESS AROUND THE TUBE SITE AFTER PLACEMENT. RPTR STATED THE PT HAD A "GREEN AND BROWN INFECTION AND LOST WEIGHT". A PRESCRIBED TOPICAL ANTIBIOTIC WAS APPLIED. RPTR STATED THE PT NOW WEIGHS 11 POUNDS AND HAS NOT USED THE TUBE IN A FEW WEEKS. NOTE: THE EVENT DATE GIVEN ABOVE IS APPROXIMATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROSS HIDE-A-PORT GASTROSTOMY KIT | 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES | KNT | ROSS PRODUCTS DIV. ABBOTT LABORATORIES, INC. | 54146 | 49-834-GZ, 58-314-GZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | Required Intervention |