FDA Adverse Event
Malfunction
Summary report: N
1000ML FREEDOM LEGBAG, TWIST PORT
MDR report key: 5313565
·
Received September 29, 2004
Report
- Report Number
- 2183558-2004-00016
- Event Type
- Malfunction
- Date Received
- September 29, 2004
- Report Date
- September 1, 2004
- Manufacturer
- MENTOR CORPORATION - MINNESOTA DIV.
- Product Code
- EXJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THE RETURN OF THE LEG BAG HAS BEEN REQUESTED. AT THIS TIME, NO PRODUCT HAS BEEN RECEIVED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PRODUCT OR THE CAUSE FOR THIS OCCURRENCE. SHOULD THE PRODUCT BE RECEIVED, QA WILL FILE AN ADDENDUM TO THIS REPORT IF REQUIRED.
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION, THE PATIENT'S WIFE STATES HER HUSBAND'S LEG BAG FLUTTER VALVE WAS SEALED SHUT. THIS CAUSED HIM TO NOT BE ABLE TO EMPTY HIS BLADDER AND RESULTED IN A BLADDER INFECTION. THE PATIENT WAS PUT ON ANTIBIOTICS TWICE, WITH NO RESULTS. THE DOCTOR PUT THE PATIENT ON A DIFFERENT ANTIBIOTIC, BUT THIS ANTIBIOTIC CAUSED AN ALLERGIC REACTION (STEVENS JOHNSON SYNDROME) AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1000ML FREEDOM LEGBAG, TWIST PORT | LEGBAG PRODUCTS | EXJ | MENTOR CORPORATION - MINNESOTA DIV. | 28-07096 | 1707047096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR |