MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OTHER HEADS COCR; COCR 12/14 FEM HD 32 + 0

Catalog Number 71303200

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Erythema (1840)

Event Date 03/29/2011

Event Type  Injury  

Event Description

Patient seen for erythema left hip wound with mild induration/possible cellulitis; treated with duricef.

• Brand Name: OTHER HEADS COCR
• Type of Device: COCR 12/14 FEM HD 32 + 0
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: carla samuels ; 1450 brooks road; memphis, TN 38116 ; 9013995076
• MDR Report Key: 4737643
• MDR Text Key: 5703084
• Report Number: 1020279-2015-00229
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K854791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2014

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: 71303200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 04/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR