MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC

Model Number UNK SURGIPRO MESH

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Hernia (2240); Injury (2348); 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 hernia.It was reported that after implant, the patient experienced adhesions and hernia recurrence.Post-operative patient treatment included revision and removal surgery.

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 recurrent ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, epigastric pain, difficulty eating, diverticulitis, uti, dyspepsia, gerd, propylene mesh had pulled from the sidewall and the loose propylene had not incorporated, foreign body reaction, scar tissue, adipose tissue, infection, pain, and inflammation.Post-operative patient treatment included revision surgery, lysis of adhesions, wound vac, laparoscopic components parts release, open appendectomy, placed in icu, and removal surgery.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.(b)(4).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 recurrent ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, epigastric pain, difficulty eating, diverticulitis, uti, dyspepsia, gerd, propylene mesh had pulled from the sidewall and the loose propylene had not incorporated, foreign body reaction, scar tissue, adipose tissue, infection, and inflammation.Post-operative patient treatment included revision surgery, lysis of adhesions, wound vac, laparoscopic components parts release, open appendectomy, placed in icu, and removal surgery.

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 recurrent ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, epigastric pain, difficulty eating, diverticulitis, uti, dyspepsia, gerd, propylene mesh had pulled from the sidewall and the loose propylene had not incorporated, inflammation.Post-operative patient treatment included revision and removal surgery.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 8095981
• MDR Text Key: 128085062
• Report Number: 1219930-2018-06224
• 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,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK SURGIPRO MESH
• Device Catalogue Number: UNK SURGIPRO MESH
• Device Lot Number: A1M148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 105