MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-13 for KENDALL TYCO HEALTHCARE MONO-FLO DRAINAGE BAG - 2000 ML 6308LL manufactured by Tyco/kendall.
[2796000]
The device on the drainage tubing sticks up at least 1/4 an inch. This is where a syringe is inserted to draw urine from the tubing. This has caused multiple scratches on the inside of the thighs. This then bleeds and may take several weeks to heal. Persons that use this usually are old, frail, or have major medical conditions. This could cause infections as this skin is now scratched. This is a safety issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026610 |
| MDR Report Key | 2713628 |
| Date Received | 2012-08-13 |
| Date of Report | 2012-08-13 |
| Date of Event | 2012-08-06 |
| Date Added to Maude | 2012-08-27 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 TYCO HEALTHCARE MONO-FLO DRAINAGE BAG - 2000 ML |
| Generic Name | DRAINAGE BAG |
| Product Code | FCN |
| Date Received | 2012-08-13 |
| Catalog Number | 6308LL |
| ID Number | 131155164 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-13 |