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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091); Anxiety (2328); Irritability (2421)

Event Date 11/14/2020

Event Type  Injury  

Manufacturer Narrative

A patient sent sofregen medical a letter detailing "persistent symptoms of abdominal pain, anxiety, swelling, abdominal protrusions, hardness in certain areas of my abdomen and itching and irritability" after undergoing abdominoplasty, where a seri scaffold device was allegedly implanted in the patient's abdomen to provide additional tissue support.These issues persisted for months and after exhausting all non-surgical measures to relieve the patient of her symptoms, it was agreed upon by the patient and the implanting physician to perform a revision surgery.The patient stated that a portion of the seri scaffold device did not integrate into the tissue and this portion of the mesh was removed surgically.Additionally, the patient stated that a portion of the seri scaffold device integrated with the abdominal tissue and remained implanted in the abdomen.Sofregen interviewed the patient to begin the complaint investigation process.Sofregen requested access to the medical records and permission to contact the physician.The patient refused consent for sofregen to contact the physician immediately and requested that sofregen reach back out to obtain consent at a later date.This adverse event is treated as confirmed but further investigation and confirmation is necessary.A root cause analysis cannot be performed at this time.If the patient provides consent to contact the physician and obtain medical records sofregen will perform an investigation and attempt to determine root cause.

Event Description

A patient sent sofregen medical a letter detailing "persistent symptoms of abdominal pain, anxiety, swelling, abdominal protrusions, hardness in certain areas of my abdomen and itching and irritability" after undergoing abdominoplasty, where a seri scaffold device was allegedly implanted in the patient's abdomen to provide additional tissue support.These issues persisted for months and after exhausting all non-surgical measures to relieve the patient of her symptoms, it was agreed upon by the patient and the implanting physician to perform a revision surgery.The patient stated that a portion of the seri scaffold device did not integrate into the tissue and this portion of the mesh was removed surgically.Additionally, the patient stated that a portion of the seri scaffold device integrated with the abdominal tissue and remained implanted in the abdomen.Sofregen interviewed the patient to begin the complaint investigation process.Sofregen requested access to the medical records and permission to contact the physician.The patient refused consent for sofregen to contact the physician immediately and requested that sofregen reach back out to obtain consent at a later date.This adverse event is treated as confirmed but further investigation and confirmation is necessary.A root cause analysis cannot be performed at this time.If the patient provides consent to contact the physician and obtain medical records sofregen will perform an investigation and attempt to determine root cause.

• Brand Name: SERI SURGICAL SCAFFOLD
• Type of Device: SERI SCAFFOLD
• Manufacturer (Section D): SOFREGEN MEDICAL; 200 boston ave suite 1100; medford MA 02155
• Manufacturer Contact: 200 boston ave suite 1100; medford, MA 02155
• MDR Report Key: 11151683
• MDR Text Key: 231799027
• Report Number: 3013417188-2020-00007
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 12/15/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention