MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES UNKNOWN PELVICOL PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNK PELVICOL

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Gastritis (1874); Incontinence (1928); Irritation (1941); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348); Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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.Additional information has been requested, but not yet received.The preoperative diagnosis and postoperative diagnosis was sui.The procedure performed was a bladder mesh sling.Per additional information received, the patient has experienced suprapubic/right lower abdominal pain (abdominal pain), urinary frequency, uncontrollable urinary leakage, post-menopausal, constipation, mixed/urge/stress incontinence, pain in stomach, leakage, vaginal discharge, vaginal irritation, urinary frequency, elevated body mass index, chronic back pain, colon polyps/diverticulosis, depression, fatigue, weight up/down (weight fluctuations), sleeping poorly (sleep disturbances), chronic antral gastritis, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

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

• Brand Name: UNKNOWN PELVICOL PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6413036
• MDR Text Key: 70301573
• Report Number: 9617613-2017-05039
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• 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: 02/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: IN-FAST
• Patient Outcome(s): Other; Required Intervention