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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN / SOFREGEN MEDICAL INC. SERI SCAFFOLD MESH; MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
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ALLERGAN / SOFREGEN MEDICAL INC. SERI SCAFFOLD MESH; MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Chest Pain (1776); Hematoma (1884); Seroma (2069); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/13/2020
Event Type  Injury  
Event Description
The surgeon used "seri scaffold mesh" (b)(6) on breast implant exchange, causing seroma, hematoma, double encapsulation, left arm muscle numbness.Still, more exams to determine chest pain and other issues with breast tissue.Seri scuffed mesh was out of the market twice.The first company that owned seri was allergan, and it was sued in 2013.The company was acquired by another company and sued in 2016.Seri's website does not advertise the usage of this mesh for a breast implant; why are they still selling it? i want to know what steps to follow about the product as i am taking steps directly with the doctor on why is he using this product.Additional tests as mri, aspiration of the liquid mass for biopsy and lab tests are programmed this week before a second surgery is done to take the implants and the seri scaffold mesh out.Fda safety report id# (b)(4).
 
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Brand Name
SERI SCAFFOLD MESH
Type of Device
MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
Manufacturer (Section D)
ALLERGAN / SOFREGEN MEDICAL INC.
MDR Report Key11737660
MDR Text Key248053088
Report NumberMW5101033
Device Sequence Number1
Product Code OXF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/13/2020
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age52 YR
Patient Weight57
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