MAUDE Adverse Event Report: STRYKER GMBH ENDOTRAC EGR-D; ACCESSORIES,ARTHROSCOPIC

Catalog Number 3200-D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 01/16/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

Second inquiry from rep dated 3/17 and 3/11 reported patient developed superficial infection, cultured (b)(6).Treatment with one treatment of bactrim resolved the infection quickly.Initial use of the device.

• Brand Name: ENDOTRAC EGR-D
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6185574
• MDR Text Key: 62745714
• Report Number: 0008031020-2016-00615
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3200-D
• Device Lot Number: 130601-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention