MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-16 for FREER SEPTUM ELEVATOR 65-6620 manufactured by Codman & Shurtleff, Inc..
[37725670]
Codman has been advised that the device will not be returned for evaluation. The freer septum elevator is an instrument that is intended for use in nasal surgery. However, the customer reports a portion broke off and became embedded in the pt's shoulder. The type of surgical procedure for which this nasal elevator was determined. The complaint cannot be verified. At this time, the complaint is considered to be closed.
Patient Sequence No: 1, Text Type: N, H10
[37725671]
Per (b)(4), freer elevator broke during surgical procedure. A 2mm by 1/2cm stainless steel piece broke off and embedded in pt's soft tissue in left shoulder. Physician was unable to retrieve/remove from pt's left shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2004-00282 |
| MDR Report Key | 5410368 |
| Date Received | 2004-09-16 |
| Date of Event | 2004-07-22 |
| Date Mfgr Received | 2004-08-19 |
| Date Added to Maude | 2016-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MATHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREER SEPTUM ELEVATOR |
| Generic Name | ELEVATOR, SURGICAL, GENERAL, PLASTIC SURGERY |
| Product Code | GEG |
| Date Received | 2004-09-16 |
| Model Number | NA |
| Catalog Number | 65-6620 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-16 |