MAUDE Adverse Event Report: CL MEDICAL 1-STOP; NONE

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 11/30/2010

Event Type  No Answer Provided  

Event Description

Plaintiff's lawyer reported that patient allegedly was implanted with a cl medical i-stop (lot number, ref no unknown).Patient had another surgery for pop a year after.Patient complained about pain, erosion, additional surgeries, infections.

• Brand Name: 1-STOP
• Type of Device: NONE
• Manufacturer (Section D): CL MEDICAL; FR
• MDR Report Key: 3631554
• MDR Text Key: 3989474
• Report Number: 3006302280-2013-00002
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1