MAUDE Adverse Event Report: PFM MEDICAL TITANIUM GMBH TIMESH; SURGICAL MESH

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

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

Event Date 12/17/2004

Event Type  Injury  

Manufacturer Narrative

The risks of mesh implantation is the pelvic floor by transvaginal placement were reviewed in the risk management documentation.The risk of chronic pain is evaluated as tolerable and is a known complication.This report from (b)(6) could be an off-label use.A verified statement cannot be made without a batch number.In general the indication was originally kept very open, today the scope is limited to the treatment of hernia in all countries/regulatory areas.

Event Description

I was implanted with trans vaginal mesh which has resulted in significant health issues and pain.No part number or lot number was provided for the device.Event was occured in (b)(6) and was reported there.A similar or equivalent device is marketed in the us.Unable to provide fda product code without knowing which product was implanted.

• Brand Name: TIMESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): PFM MEDICAL TITANIUM GMBH; sudwestpark 42; nuremberg bayern, 90449 ; GM 90449
• Manufacturer (Section G): PFM MEDICAL TITANIUM GMBH; sudwestpark 42; nuremberg bayern, 90449 ; GM 90449
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008
• MDR Report Key: 8416080
• MDR Text Key: 138653177
• Report Number: 3003936139-2019-00001
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other