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

Model Number SPM-35

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)

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 laparoscopic therapeutic treatment of bilateral inguinal hernia.It was reported that after implant, the patient experienced defective mesh, failure of mesh, scarring, disfigurement, mental pain, pain, adhesions, erosion, wound dehiscence, infection, abscess, mesh not incorporated, recurrence, permanent physical deformity.Post-operative patient treatment included drainage of abscess, removal of mesh, and hernia repair with new 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: 14168114
• MDR Text Key: 289757148
• Report Number: 1219930-2022-01426
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101364
• UDI-Public: 10884521101364
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: SPM-35
• Device Catalogue Number: SPM-35
• Device Lot Number: A2H0318X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2022
• Date Device Manufactured: 09/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability