MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿; MESH, SURGICAL

Model Number P152040

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Calcium Deposits/Calcification (1758); Fistula (1862); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Hernia (2240); Injury (2348); Impaired Healing (2378); Fungal Infection (2419); Obstruction/Occlusion (2422); Organ Dehiscence (2502); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191)

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, calcification/hardening of mesh, fistula, infection, uti, obstruction, hernia recurrence, chronic pain, abdominal pain, distended small bowel, chronic non-healing surgical wound, fungemia, anemia, severe protein energy malnutrition, granulation tissue base, weight loss, lower abdominal dehiscence with skin graft, and prolonged hospitalization including sepsis.Post-operative patient treatment included bowel removal, surgical revisions ((b)(6) 2014, (b)(6) 2015, (b)(6) 2017) and mesh removal.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8321317
• MDR Text Key: 135859993
• Report Number: 9617613-2019-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P152040
• Device Catalogue Number: P152040
• Device Lot Number: 10B0102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/08/2019
• 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 Weight: 90