MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-09 for FREER SEPTUM ELEVATOR 65-6620 manufactured by Codman And Shurtleff - Raynham.
[18205992]
It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[18278372]
Medwatch report explained that orthopedic instrument, codman 28 stainless broke during use. Additional information explained; the piece was retrieved without any adverse consequences. Xray was taken to ensure piece was fully removed. No additional steps were taken. No delay greater than 30 minutes. Device is available for eval. Lot number not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2012-00192 |
| MDR Report Key | 2523931 |
| Report Source | 05,06 |
| Date Received | 2012-04-09 |
| Date of Event | 2012-02-14 |
| Report Date | 2012-03-13 |
| Date Reported to Mfgr | 2012-03-13 |
| Date Mfgr Received | 2012-03-13 |
| Date Added to Maude | 2012-04-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREER SEPTUM ELEVATOR |
| Generic Name | ELEVATOR, SURGICAL, GENERAL, PLASTIC SURGERY |
| Product Code | GEG |
| Date Received | 2012-04-09 |
| Catalog Number | 65-6620 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF - RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-09 |