FDA Adverse Event
Malfunction
Summary report: N
RUSCH BELLY BAG
MDR report key: 1592765
·
Received January 25, 2010
Report
- Report Number
- 3004365956-2010-00005
- Event Type
- Malfunction
- Date Received
- January 25, 2010
- Report Date
- January 8, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KNX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEFECTIVE PRODUCT HAS BEEN REQUESTED, BUT NOT RECEIVED IN TIME FOR THIS REPORT. IF PRODUCT AND LOT NUMBER ARE RECEIVED, A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: A PARALYZED HOME CARE CUSTOMER STATES, THE EMPTYING NOZZLE ALLEGEDLY CAUSED AN INFECTION IN HIS LEG AND TESTICLES WHERE IT CAME IN CONTACT WITH HIS SKIN. HE WAS PUT ON ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH BELLY BAG | BELLY BAG | KNX | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |