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Adverse Event Report

E. BENSON HOOD LABORATORIES NEONATE TRACHEOSTOMY TUBE   back to search results
Model Number 10035
Event Date 07/01/1995
Event Type  Death   Patient Outcome  Death;
Event Description

The initial report to co that a neonate tracheostomy tube fractured after being in a pt for 282 days came to co via a fax from engineer. He stated that the neonate tube was in the pt between 9/22/94 & 7/1/95. The info received to date indicates that the tracheostomy tube fractured and may have contributed to the asphyxiation of the pt. The subject tracheostomy tube is alleged to have been mfg by co. This is all the info co has at this time. A full investigation is underway.

 
Manufacturer Narrative

A request to obtain the fractured device has been issued. When the device is returned it will be evaluated and the mfr of the device will be confirmed. A fracture is unlikely due to the high tensile strength and elongation characteristics of the material used in tracheostomy tubes mfg by co. The length of time in situ reported is unusual. Common practice in the use of a tracheostomy tube follows a schedule of daily cleaning and weekly changing of the tube. Co mfrs only disposable trach tubes. It would be difficult to maintain a smaller diameter tube for over 9 months without replacing it.

 
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Brand NameNEONATE TRACHEOSTOMY TUBE
Type of DeviceTRACHEOSTOMY TUBE
Baseline Brand NameNEONATAL TRACHEOSTOMY TUBE
Baseline Generic NameTRACHEOSTOMY TUBE
Baseline Catalogue Number10035
Baseline Model Number10035
Baseline Device FamilyTHORACIC PLASTIC/SILICONE DEVICES
Baseline Device 510(K) NumberK893866
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/07/1989
Date Ceased Marketing09/30/1998
Manufacturer (Section F)
E. BENSON HOOD LABORATORIES
575 washington st
pembroke MA 02359
Manufacturer (Section D)
E. BENSON HOOD LABORATORIES
575 washington st
pembroke MA 02359
Manufacturer (Section G)
E. BENSON HOOD LAB, INC.
575 washington st.
pembroke MA 02359
Manufacturer Contact
lewis marten
575 washington st
pembroke , MA 02359
(781) 826 -7573
Device Event Key59460
MDR Report Key59027
Event Key55468
Report Number1220850-1996-00002
Device Sequence Number1
Product CodeBTO
Report Source Manufacturer
Source Type Foreign
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 12/26/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number10035
Device Catalogue Number10035
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received12/03/1996
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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