MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-08-22 for ROUND TIP URETHRAL CATHETER 332104 manufactured by Rusch Manufacturing (uk) Ltd..
[15683948]
Tip was almost broken off. Product was being used in a duct, not in urethra. Health workers did not notice tip almost off. Since product was being used in a duct there was no damage or injury to pt as size of duct is larger than urethra.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010095-1996-00050 |
| MDR Report Key | 36080 |
| Report Source | 06 |
| Date Received | 1996-08-22 |
| Date of Report | 1996-08-22 |
| Date Mfgr Received | 1996-08-21 |
| Date Added to Maude | 1996-08-30 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROUND TIP URETHRAL CATHETER |
| Generic Name | CATHETER |
| Product Code | FCS |
| Date Received | 1996-08-22 |
| Model Number | NA |
| Catalog Number | 332104 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 37501 |
| Manufacturer | RUSCH MANUFACTURING (UK) LTD. |
| Manufacturer Address | PO BOX 138, HALIFAX RD CRESSEX INDUSTRIAL ESTATE BUCKINGHAMSHIRE UK HP123NB |
| Baseline Brand Name | ROUND TIP URETHRAL CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 332104 |
| Baseline ID | NA |
| Baseline Device Family | URETHRAL CATHETER |
| Baseline Shelf Life Contained | * |
| 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 | 1996-08-22 |