MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTPUMP DUAL CHANNEL; TOURNIQUET, PNEUMATIC

Catalog Number 5920011000

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

Patient Problem Pain (1994)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported that following the completion of a surgical procedure at the user facility, the patient experienced pain on the right bicep where the tourniquet had been placed and required pain medication to be applied to the area.The procedure was completed successfully.No delay was reported.

Event Description

It was reported that following the completion of a surgical procedure at the user facility, the patient experienced pain on the right bicep where the tourniquet had been placed and required pain medication to be applied to the area.The procedure was completed successfully.No delay was reported.

Manufacturer Narrative

The device was not returned for analysis; it is not possible to determine the cause of the reported event without an evaluation of the device.

• Brand Name: SMARTPUMP DUAL CHANNEL
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4303888
• MDR Text Key: 5267387
• Report Number: 0001811755-2014-04400
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5920011000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 5921018235, DISP 18X3 1BLA 2PRT QUICK, S/N UNKNOWN