MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-29 for 1000ML FREEDOM LEGBAG, TWIST PORT 28-07096 manufactured by Mentor Corporation - Minnesota Div..
[37618764]
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.
Patient Sequence No: 1, Text Type: N, H10
[37618785]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183558-2004-00016 |
| MDR Report Key | 5313565 |
| Date Received | 2004-09-29 |
| Date of Report | 2004-09-01 |
| Date Facility Aware | 2004-09-01 |
| Date Mfgr Received | 2004-09-01 |
| Date Added to Maude | 2015-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANNE WYATT, MENTOR |
| Manufacturer Street | 1525 W. RIVER ROAD N. |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122874222 |
| Manufacturer G1 | MENTOR CORPORATION - MINNESOTA DIV |
| Manufacturer Street | 1615 WEST RIVER RD., NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 1000ML FREEDOM LEGBAG, TWIST PORT |
| Generic Name | LEGBAG PRODUCTS |
| Product Code | EXJ |
| Date Received | 2004-09-29 |
| Model Number | 28-07096 |
| Catalog Number | 28-07096 |
| Lot Number | 1707047096 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR CORPORATION - MINNESOTA DIV. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-29 |