MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-04-16 for CURITY MONO-FLO DRAIN BAG * 6308 manufactured by Kendall Company.
[17024724]
Incomplete drainage of bladder with retention of 500ml of urine. Patient had sharp pain. Removed catheter and bag. Neither the tubing or catheter were kinked or twisted. No medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2001-00003 |
| MDR Report Key | 328073 |
| Report Source | 07 |
| Date Received | 2001-04-16 |
| Date of Report | 2001-04-12 |
| Report Date | 2001-04-12 |
| Date Mfgr Received | 2001-04-09 |
| Date Added to Maude | 2001-04-24 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURIE PANNELLA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY MONO-FLO DRAIN BAG |
| Generic Name | DRAIN BAG |
| Product Code | FON |
| Date Received | 2001-04-16 |
| Model Number | * |
| Catalog Number | 6308 |
| Lot Number | 80504 |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 317466 |
| Manufacturer | KENDALL COMPANY |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US |
| Baseline Brand Name | CURITY MONO-FOL DRAIN BAG |
| Baseline Generic Name | DRAIN BAG |
| Baseline Model No | NA |
| Baseline Catalog No | 6308 |
| Baseline Device Family | CURITY MONO-FLO DRIAN BAG |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K852085 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-04-16 |