MAUDE Adverse Event Report:; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN MESH

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

Patient Problems Pain (1994); Urinary Frequency (2275); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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 preoperative and postoperative diagnosis was pelvic pain, urinary frequency, urinary hesitancy and limited bladder capacity.The procedure performed was cystoscopy with hydrodistention and urethral dilation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.There is no documentation of mesh implantation; however, on (b)(6) 2016 the mesh was palpable on exam under anesthesia.The preoperative and postoperative diagnosis was pelvic pain, urinary frequency, urinary hesitancy and limited bladder capacity.The procedure performed was cystoscopy with hydrodistention and urethral dilation.An additional surgery was done on (b)(6) 2016, for post hysterectomy cystocele, rectocele, and vaginal wall prolapse.No mesh was encountered during this procedure.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7336722
• MDR Text Key: 102304136
• Report Number: 1219930-2018-01473
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MESH
• Device Catalogue Number: UNKNOWN MESH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2018
• 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; Required Intervention
• Patient Age: 57 YR