MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-10 for CODMAN 65-6620 manufactured by Codman.
[39762406]
Freer elevator broke during surgical procedure, 2mm by 1/2cm stainless steel piece broke off and embedded into pt's soft tissue in left shoulder. Physician was unable to retrieve/remove from pt's left shoulder. Mfr #1226348-2004-00282.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5479866 |
| MDR Report Key | 5479866 |
| Date Received | 2004-09-10 |
| Date of Report | 2004-08-10 |
| Date of Event | 2004-11-22 |
| Date Facility Aware | 2004-07-30 |
| Report Date | 2004-08-10 |
| Date Added to Maude | 2016-03-04 |
| 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 | 0 |
| Brand Name | CODMAN |
| Generic Name | FREER ELEVATOR |
| Product Code | GEG |
| Date Received | 2004-09-10 |
| Catalog Number | 65-6620 |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN |
| Manufacturer Address | RANDOLPH MA 02368 US 02368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-10 |