MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 1998-02-18 for PHILLIPS CATHETER FOLLOWER 346120 manufactured by Rusch Inc..
[88964]
It has been reported that the threads were stripped on tip. Product was used on pt, then washed, then placed in a bag. No pt injury. No further info given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1998-00004 |
| MDR Report Key | 150424 |
| Report Source | 04,06 |
| Date Received | 1998-02-18 |
| Date of Report | 1998-02-17 |
| Date of Event | 1998-02-12 |
| Date Mfgr Received | 1998-02-13 |
| Device Manufacturer Date | 1996-04-01 |
| Date Added to Maude | 1998-02-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILLIPS CATHETER FOLLOWER |
| Generic Name | URETHERAL FOLLOWER |
| Product Code | FAX |
| Date Received | 1998-02-18 |
| Model Number | NA |
| Catalog Number | 346120 |
| Lot Number | E961403 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 146571 |
| Manufacturer | RUSCH INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | PHILLIPS CATHETER FOLLOWER |
| Baseline Generic Name | URETHRAL FOLLOWERS |
| Baseline Model No | NA |
| Baseline Catalog No | 346120 |
| Baseline ID | NA |
| Baseline Device Family | URETHRAL FOLLOWERS - DISPOSABLE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-02-18 |