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 04/21/2005

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Patient underwent multiple corrective surgeries, removal of part of the pelvic mesh device.Extreme pain, discomfort, urinary problems, dyspareunia.

Manufacturer Narrative

After review it was determined that this report is a duplicate of mfr#9617613-2016-00129.All further updates will be reported under mfr#9617613-2016-00129.

• 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 ave; north haven, CT 06473
• MDR Report Key: 6197976
• MDR Text Key: 63070601
• Report Number: 9617613-2016-00144
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• 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