MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-04 for GRIP-TIP URETHRAL SUTURE GUIDE U515 manufactured by Greenwald Surgical Co, Inc.
[377234]
Co would not provide time nor temperature for product purchased. The document received from the co only states "steam autoclaving is recommended. " no parameters were given for an instrument that has a channel for retraction of prongs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034866 |
| MDR Report Key | 579816 |
| Date Received | 2005-03-04 |
| Date of Report | 2005-03-04 |
| Date of Event | 2005-03-03 |
| Date Added to Maude | 2005-03-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GRIP-TIP URETHRAL SUTURE GUIDE |
| Generic Name | URETHRAL SOUND WITH RETRACTABLE PRONGS |
| Product Code | FBX |
| Date Received | 2005-03-04 |
| Model Number | U515 |
| Catalog Number | U515 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 569664 |
| Manufacturer | GREENWALD SURGICAL CO, INC |
| Manufacturer Address | 2688 DEKALB ST LAKE STATION IN 464051519 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-04 |