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 Micturition Urgency (1871); Inflammation (1932); Itching Sensation (1943); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Fungal Infection (2419); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

(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.The preoperative and postoperative diagnosis was stress urinary incontinence.The procedure performed was an in-fast urethral sling with trocar cystostomy and vaginal hysterectomy.Between 8 days and 1 month post op the patient had incomplete bladder emptying, urinary retention, and bladder spasms.She was prescribed utira.Between 2 months and 5 months post op the patient had low back pain, painful urination for 2 to 3 days, frequency, urgency during the daytime, bladder spasm, urinary tract infection, and atrophic vaginitis treated with estrace ring.She was assessed with bladder outlet obstruction probably secondary to her sling.Between 2 years and 3 months and 2 years and 4 months the patient had vaginal discharge with itching, discomfort.There was yeast present and it was treated with diflucan.She was prescribed ciprofloxacin and pyridium.

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.

• 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: 6415471
• MDR Text Key: 70301614
• Report Number: 9617613-2017-05040
• 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
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: 02/15/2017
• Supplement Dates FDA Received: 10/02/2017
• 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: AMS IN-FAST BONE ANCHOR
• Patient Outcome(s): Other