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

Model Number SPMM-35

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Perforation (2001); Sepsis (2067); Seroma (2069); Hernia (2240); Ulcer (2274); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was ventral hernia.­­­­­­­­­ the procedure performed was robot-assisted ventral hernia repair with mesh.She has had surgical revision, adhesions, and abscess.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.Product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced adhesions, abscess, seroma, perforated ulcer, pneumoperitoneum, abdominal pain, experienced lethargy, sepsis and recurrence.Post-operative patient treatment included revision surgery, lysis of adhesions, drainage of seroma, partial omentectomy, excision of previous mesh, drainage of abscess, evacuation of coagulated blood and enteric contents/debris, mobilization of right colon with kochers maneuver, primary repair of posterior d2 perforated ulcer with omental patch reinforcement, abdominal washout, and repair of hernia.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt.  due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.Product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced adhesions, abscess, seroma, perforated ulcer, and recurrence.Post-operative patient treatment included revision surgery, lysis of adhesions, drainage of seroma, partial omentectomy, excision of previous mesh, drainage of abscess, evacuation of coagulated blood and enteric contents/debris, mobilization of right colon with kochers maneuver, primary repair of posterior d2 perforated ulcer with omental patch reinforcement, abdominal washout, and repair of hernia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN SURGIPRO MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; ct 06473
• MDR Report Key: 7174717
• MDR Text Key: 96718247
• Report Number: 1219930-2018-00238
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: SPMM-35
• Device Catalogue Number: SPMM-35
• Device Lot Number: A4K1427X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKABSTACK(LOT#: UNKNOWNO
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 90