MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-26 for UROLOGY TECH * manufactured by Urologytech.
[260324]
Ddv ligator, item # 1001, mfg by urology tech was received with a plain white tyvek peel pack - no name of item, no word "sterile", no mfr's name, no expiration date (item contains chromic suture). The co rep was called. He came to the hosp, affixed a label to the existing inventory and wrote the "sterile lot#" on the labels in pen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026014 |
| MDR Report Key | 413797 |
| Date Received | 2002-08-22 |
| Date of Report | 2002-08-22 |
| Date of Event | 2002-08-15 |
| Date Added to Maude | 2002-09-03 |
| 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 |
| 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 | UROLOGY TECH |
| Generic Name | DDV LIGATOR |
| Product Code | KOA |
| Date Received | 2002-08-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 402836 |
| Manufacturer | UROLOGYTECH |
| Manufacturer Address | PO BOX 94675 LUBBOCK TX 79493 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-08-22 |