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

Model Number SMHP-02

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: strattice (lot# sp100089-405), floseal hemostatic matrix 5 ml (lot# ha130740), vascu-guard (lot# spge114-05e 0040), smhp-02 surgipro* mesh und sml patchx3 (lot# sa4e0049x). 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 right inguinal hernia. It was reported that after implant, the patient experienced groin pain, hernia recurrence, mesh detachment, and scarring. Post-operative patient treatment included revision surgery and surgery to remove one of the implanted meshes.

• 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: 12417800
• MDR Text Key: 269663259
• Report Number: 9615742-2021-02130
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982575
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2019
• Device Model Number: SMHP-02
• Device Catalogue Number: SMHP-02
• Device Lot Number: A4E0049X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/01/2014
• 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: 09/02/2021 Patient Sequence Number: 1