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

Model Number UNKNOWN SURGIPRO MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Seroma (2069); Hernia (2240); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title intra-abdominal giant infected seroma following laparoscopic inguinal hernia repair source hernia, volume 19, 2015 (795¿797) date of publication: 26 october 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed on 2015, the patient underwent laparoscopic transabdominal preperitoneal inguinal hernia repair for the left and right sides and was discharged on the same day and followed up at seven weeks and one year without complication.Six years later, the patient presented with abdominal and right lower limb pain and non-tender, immobile mass and was confined to the lower abdomen; upon ct scan, a large cystic mass confined by a thick contrast enhancing rim 17 x 15 x 16 cm determined to be an infected seroma.They drained and exploration of the cavity was performed under anesthesia.There was no recurrence after 6 months.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8958554
• MDR Text Key: 156393349
• Report Number: 1219930-2019-05012
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SURGIPRO MESH
• Device Catalogue Number: UNKNOWN SURGIPRO MESH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• 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
• Patient Age: 80 YR