MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNK PELVICOL

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

Patient Problems Pain (1994); Discomfort (2330); Injury (2348)

Event Date 06/07/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mfr date: since the lot number was not provided, this information cannot be determined.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient was implanted with a mesh device.After the device was implanted, the patient began to experience severe complications related to the implant, including but not limited to extreme pain, discomfort, urinary problems, dyspareunia and upon information and believe may have underwent multiple corrective surgeries to remove or part of the pelvic mesh device.

Manufacturer Narrative

(b)(4).It was determined that this complaint is a duplicate of a previously reported complaint: (b)(4).(refer to mdr report #9617613-2016-00116).

• Brand Name: UNKNOWN PELVICOL PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer (Section G): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6216725
• MDR Text Key: 63689213
• Report Number: 9617613-2016-00149
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention