MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for LONE STAR 3304G manufactured by Cooper Surgical, Inc.
[38771035]
Patient Sequence No: 1, Text Type: N, H10
[38771036]
Retractor was opened and failed. It was noticed to be missing one grey lock screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5453472 |
| MDR Report Key | 5453472 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-01-14 |
| Date of Event | 2015-12-21 |
| Report Date | 2016-01-14 |
| Date Reported to FDA | 2016-01-14 |
| Date Reported to Mfgr | 2016-01-14 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | LONE STAR |
| Generic Name | RETRACTOR |
| Product Code | GDG |
| Date Received | 2016-02-23 |
| Model Number | 3304G |
| Lot Number | 162852 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL, INC |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL, CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-23 |