MAUDE Adverse Event Report: SOFREGEN MEDICAL SERI SURGICAL SCAFFOLD; SURGICAL MESH

Model Number SERI SURGICAL SCAFFOLD, 10 X 25CM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Pain (1994); Seroma (2069)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

A clinician informed sofregen by email of a patient who had seri surgical scaffold implanted.In an uncomplicated abdominoplasty, seri scaffold was used as an onlay on her abdominal wall following plication.The scaffold was inset using multiple 3-0 vicryl sutures throughout the material and running circumferential 2-0 pds stratafix suture.Approximately 1 year post-op, she began experiencing minor issues with fullness in her abdomen due to a large seroma.Months later, she experienced major fluid collections and an "odd ct scan" as described by her clinician.An exploratory surgical procedure was performed one month after the scan and led to removal of the intact scaffold, as well as a significant amount of debridement of the cavity it created in the soft tissues.She has since had an uneventful post-op.An investigation was performed by sofregen into allergan's manufacturing records for the lot of seri surgical scaffold that is the subject of this event.All acceptance criteria were satisfied for final lot release.

Event Description

Patient had a surgical procedure to explore recurring fluid collections in her abdomen that occurred intermittently following an abdominoplasty procedure.At the time of the exploratory surgery, the surgeon completely removed seri surgical scaffold that had been placed as an overlay during the abdominoplasty.

• Brand Name: SERI SURGICAL SCAFFOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): SOFREGEN MEDICAL; 175 crossing blvd; suite 510; framingham MA 01702
• Manufacturer (Section G): ALLERGAN; 200 boston avenue; medford MA 02155
• Manufacturer Contact: jonathan hartmann ; 175 crossing blvd; suite 510; framingham, MA 01702
• MDR Report Key: 14831155
• MDR Text Key: 295040796
• Report Number: 3013417188-2022-00001
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: SERI SURGICAL SCAFFOLD, 10 X 25CM
• Device Catalogue Number: 94680
• Device Lot Number: P13123001A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female