MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-23 for KENDALL MONO FLO 6208 manufactured by Tyco Healthcare Group.
[15005450]
Pt's caregiver changed the foley catheter drainage bag and the tubing for urine to drain into the bag was noted to be permanently kinked where the urine would drain into the collection bag. The caregiver saved the info for me to report as i am the pt's weekly visiting home care nurse. Fortunately, the pt had an extra collection bag, as the dme supply co has been rationing her supplies. The pt is a quadriplegic and requires an ongoing foley catheter for urinary elimination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007783 |
| MDR Report Key | 1081410 |
| Date Received | 2008-07-23 |
| Date of Report | 2008-07-23 |
| Date of Event | 2008-07-20 |
| Date Added to Maude | 2008-08-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 2008-07-23 |
| Model Number | MONO FLO |
| Catalog Number | 6208 |
| Lot Number | 814050864 |
| Device Expiration Date | 2013-05-01 |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1050048 |
| Manufacturer | TYCO HEALTHCARE GROUP |
| Manufacturer Address | MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-23 |