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

Model Number 482027

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Bowel Perforation (2668); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

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.The product was implanted as a sling for therapeutic treatment of in continence and grade-3 cystocele.It was reported that after implant, the patient experienced perforated bowel, prolapse recurrence with large enterocele as well as cystocele, pain, erosion, extrusion, inflammation, abdomen abscess pocket, infection, unspecified urinary/bowel problems, dyspareunia, adhesions, abdomen/feculent material discharge, fascial dehiscence, fibrinous exudate material, stress urinary incontinence recurrence, blood loss, urinary tract infection, and urinary frequency.Post-operative patient treatment included exploratory laparotomy, small bowel resection, cystoscopy, sacral colpopexy, and implant of new mesh.

Manufacturer Narrative

Corrected information: h6 removed patient codes e1901 (infection, bacterial) and e2114 (perforation).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Correction to g3 (mfg aware date) in the initial report.The new information within the submitted mdr was received on 17 nov 2020.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Comment for previous report: this event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PELVICOL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• MDR Report Key: 10868715
• MDR Text Key: 217131164
• Report Number: 9617613-2020-00082
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2004
• Device Model Number: 482027
• Device Catalogue Number: 482027
• Device Lot Number: 02A19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM; PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 82