MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿; MESH, SURGICAL, POLYMERIC

Model Number UNK PELVICOL

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

Patient Problems Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Discharge (2225); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference number: (b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.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 preoperative diagnosis was pelvic pain, fibroid on ultrasound, hydrosalpinx on ultrasound, and genuine stress urinary incontinence.The postoperative diagnosis was pain, fibroid on ultrasound, hydrosalpinx on ultrasound, genuine stress urinary incontinence, adhesions on the right pelvic sidewall around the appendix and bowel and colon to the pelvic sidewall, bilateral hydrosalpinx, a 3- to 4-cm simple-appearing right ovarian cyst, and a small fibroid noted in the uterus.The procedure performed was a laparoscopic -assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, pubovaginal sling, and cystoscopy.In (b)(6) 2005 the patient complained of incontinence, which was mostly urge incontinence, and discharge.In (b)(6) 2007 the patient had a vaginal culture which showed presence of yeast like fungi.In (b)(6) 2007 the patient was assessed with vaginitis and vulvovaginitis.She complained of dark urine.In (b)(6) 2009 the patient was assessed with postmenopausal atrophic vaginitis.Between (b)(6) 2010 the patient complained of pelvic pain and vaginal bleeding.She was assessed with postmenopausal atrophic vaginitis.

Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic complaint report: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH TSL - PELVICOL¿
• 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: 6432031
• MDR Text Key: 70788608
• Report Number: 9617613-2017-05046
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• 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: 12/27/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 49