FREER SEPTUM ELEVATOR 65-6620

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1226348-2004-00282
MDR Report Key5410368
Date Received2004-09-16
Date of Event2004-07-22
Date Mfgr Received2004-08-19
Date Added to Maude2016-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMATHEW KING
Manufacturer Street325 PARAMOUNT DR.
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088283106
Manufacturer G1CODMAN & SHURTLEFF, INC.
Manufacturer Street325 PARAMOUNT DR.
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameFREER SEPTUM ELEVATOR
Generic NameELEVATOR, SURGICAL, GENERAL, PLASTIC SURGERY
Product CodeGEG
Date Received2004-09-16
Model NumberNA
Catalog Number65-6620
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-09-16

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