MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-12 for KENDALL MONO-FLO 6208 * manufactured by Tyco Healthcare Group.
[16396898]
Pt's caregiver was doing a monthly catheter change and when the equipment was connected the kink prevented appropriate to gravity flow of urine. The caregiver had 2 products in possession with the kink noted in the drainage tubing. Visiting nurse sees the pt weekly. The equipment is defective.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1032072 |
MDR Report Key | 527614 |
Date Received | 2004-04-12 |
Date of Report | 2004-04-30 |
Date of Event | 2004-04-10 |
Date Added to Maude | 2004-06-03 |
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 | 0 |
Report to FDA | 0 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | KENDALL MONO-FLO |
Generic Name | FOLEY CATHETER DRAINAGE BAGS |
Product Code | FCN |
Date Received | 2004-05-12 |
Model Number | 6208 |
Catalog Number | * |
Lot Number | 235051164 |
ID Number | * |
Device Expiration Date | 2007-12-16 |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 516782 |
Manufacturer | TYCO HEALTHCARE GROUP |
Manufacturer Address | * MANSFIELD MA 02048 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 1 | 1. Other | 2004-04-12 |