MAUDE Adverse Event Report: TISSUE SCIENCE LABOR (INACTIVE) UNKNOWN PELVICOL PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNK PELVICOL

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

Patient Problems Bacterial Infection (1735); Fatigue (1849); Micturition Urgency (1871); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275); Injury (2348); Blood Loss (2597); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot number not provided.Udi not provided.Re-processing information not provided.Since the lot number was not provided, this information cannot be determined.Occupation of initial reporter not provided.(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.Product was used for therapeutic treatment.Per additional information received, the patient has experienced blood loss, urinary tract infection, bacterial infection,dysuria, chills, flank pain (pain), frequency (urinary frequency), nausea, fatigue, urgency (urinary urgency), and required non-surgical interventions.

Manufacturer Narrative

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.Product was used for therapeutic treatment.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 endometriosis, chronic pelvic pain, and genuine urinary stress incontinence.The procedure performed was a laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, laparoscopic appendectomy, pubovaginal sling repair with placement of suprapubic catheter, cystoscopy, and anterior colporrhaphy.The patient returned for an office visit on (b)(6) 2013 for an office visit for dysuria, a<(>&<)>p/imp, uti (lower urinary tract infection), dysuria, and flank pain.

Manufacturer Narrative

Tracking number: pe:(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

Alleged outcomes attributed to device include pain, infection, urinary problems, and dyspareunia.

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 LABOR (INACTIVE); victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABOR (INACTIVE); victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6329922
• MDR Text Key: 67394199
• Report Number: 9617613-2017-05000
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• 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: 02/08/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 28 YR