MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN SOFRADIM MESH; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN SOFRADIM MESH

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Inflammation (1932); Pain (1994); Perforation (2001); Skin Discoloration (2074); Injury (2348); Impaired Healing (2378); Ascites (2596); Blood Loss (2597); No Code Available (3191)

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 used for therapeutic treatment of vaginal prolapse.It was reported that after implant, the patient experienced right buttock fluid collection concerning for abscess, right gluteal pain, inflammation, purulent drainage, chronic vaginal bleeding, discoloration, piece of mesh protruding from soft tissues into the rectum, adhesions, vaginal pain, non-healing gluteal abscess related to mesh, rectovaginal fistula and rectal mesh perforation.Post-operative patient treatment included incision and drainage of right gluteal abscess with exam of anus/distal rectum under anesthesia, excision of right buttock soft tissue wound, and mesh removal.

Manufacturer Narrative

Correction: h6(removed fdd code c63248) 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

Additional information: b5, d6, g4 h6:patient code-(b)(6) (breakdown of tract between rectum <(>&<)> vagina) 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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal prolapse.It was reported that after implant, the patient experienced right buttuck fluid collection concerning for abscess, right gluteal pain, inflammation, purulent drainage, chronic vaginal bleeding, discoloration, piece of mesh protruding from soft tissues into the rectum, adhesions, vaginal pain, non-healing gluteal abscess related to mesh, rectal mesh perforation, tract between rectum and vagina had breakdown and a rectovaginal fistula developed.Post-operative patient treatment included incision and drainage of right gluteal abscess with exam of anus/distal rectum under anesthesia, excision of right buttock soft tissue wound, mesh removal, and transvaginal mesh excision.

• Brand Name: UNKNOWN SOFRADIM MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9408696
• MDR Text Key: 168998960
• Report Number: 9615742-2019-03815
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2020

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: UNKNOWN SOFRADIM MESH
• Device Catalogue Number: UNKNOWN SOFRADIM MESH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 01/29/2020; 02/19/2020
• Supplement Dates FDA Received: 02/06/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SOFRADIM ME(LOT#: UNKNOWN); UNK SOFRADIM ME(LOT#: UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR