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

Model Number SPM-35

Device Problems Degraded (1153); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

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 significant left inguinal pain and left epididymal pain, swelling, scar tissue, hard mesh, inflammation, entanglement of the spermatic cord, chronic foreign body reaction, infection, mesh encased, recurrence, scarring, lack of adequate ingrowth, nerve damage, spermatic cord injury, failure of mesh, mental pain, disability, impairment, loss of enjoyment of life, and adhesions. Post-operative patient treatment included remove his vas deferens/epididymis and removal of mesh.

• 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: 14029069
• MDR Text Key: 288766598
• Report Number: 1219930-2022-01222
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SPM-35
• Device Catalogue Number: SPM-35
• Device Lot Number: AIE0094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 04/06/2022 Patient Sequence Number: 1