MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-19 for JARIT CROSS ACTION RETRACTORS, 4", 1"SPREAD, BLUN * 205-111 manufactured by *.
[387858]
The user facility reported that locking mechanism broke off at attachment screw while in contact with a pt. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2005-00019 |
| MDR Report Key | 604467 |
| Date Received | 2005-05-19 |
| Date of Report | 2005-05-19 |
| Date Facility Aware | 2005-04-21 |
| Date Reported to FDA | 2005-05-19 |
| Date Reported to Mfgr | 2005-05-19 |
| Date Added to Maude | 2005-05-24 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT CROSS ACTION RETRACTORS, 4", 1"SPREAD, BLUN |
| Generic Name | GENERAL OPERATING INSTRUMENTS |
| Product Code | EIG |
| Date Received | 2005-05-19 |
| Returned To Mfg | 2005-04-27 |
| Model Number | * |
| Catalog Number | 205-111 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 594255 |
| Manufacturer | * |
| Manufacturer Address | * VINZENZ SATTLER GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-19 |