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

Model Number SPM-35

Device Problems Material Perforation (2205); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Gangrene (1873); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Tachycardia (2095); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 a hernia. It was reported that after implant, the patient experienced adhesions, infection and recurrence. Post-operative patient treatment included revision 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 an incarcerated left inguinal hernia. It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, open wound and chronic drainage of the left inguinal wound. Post-operative patient treatment included revision surgery, mesh removal, exploratory laparotomy, partial colectomy, colostomy, wound vac placement due to pneumoperitoneum, takedown of colostomy, lysis of adhesions, left inguinal wound exploration due to left inguinal hernia, parastomal hernia and left inguinal hernia wound.

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 an incarcerated left inguinal hernia. It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, and chronic drainage of the left inguinal wound. Post-operative patient treatment included revision surgery.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 9147024
• MDR Text Key: 160933191
• Report Number: 1219930-2019-05540
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2017
• Device Model Number: SPM-35
• Device Catalogue Number: SPM-35
• Device Lot Number: A2M0656X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/02/2019 Patient Sequence Number: 1