MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER INTERPULSE; INTERPULSE HANDPIECE SET W/HIGH FLOW

Model Number 210-14

Device Problem Device, or device fragments remain in patient (1527)

Patient Problem Cellulitis (1768)

Event Date 03/01/2015

Event Type  Injury  

Event Description

(b)(6) 2015: i&d of the left leg.(b)(6) 2015: ct scan of the left leg showed a retained foreign object in her left leg.(b)(6) 2015: patient already scheduled for debridement of left leg.During procedure doctor removed irrigation tip from left leg.

• Brand Name: STRYKER INTERPULSE
• Type of Device: INTERPULSE HANDPIECE SET W/HIGH FLOW
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 e. milham; kalamazoo MI 49001
• MDR Report Key: 4806174
• MDR Text Key: 17633400
• Report Number: 4806174
• Device Sequence Number: 1
• Product Code: FQH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 210-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Distributor Facility Aware Date: 03/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 130