SERI SURGICAL SCAFFOLD UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-17 for SERI SURGICAL SCAFFOLD UNK manufactured by Sofregen Medical, Inc.

Event Text Entries

[82982223] On (b)(4) 2017, the following information was received via email: "had an event with seri at 3 years, being balled up and needing to be removed. In my limited experience, i have not heard of such an event. " no additional information was provided. (b)(6) 2017: dr. (b)(6) called and supplied additional information. He reported that a patient had come in 2 or 3 years ago and her breasts had bottomed out from a previous augmentation. At this time, he implanted the seri surgical mesh at the base of the breasts for extra support. Then 2 or 3 months ago, she came into the office with a lump on the underside of one breast. She was referred to a surgeon who decided to remove the lump. The lump was removed, there was scar tissue surrounding the seri mesh that was balled up. The surgeon stated the patient had a foreign body reaction. Dr. (b)(6) stated he has used the seri with no issues in the past. He was not in the office and was unable to provide lot number. He will check in with his office next week and call us back. On (b)(4) 2017: spoke with the physician again and he was unable to give any additional information. The facility were the "balled up seri" was removed would not provide any additional information to dr. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3013417188-2017-10001
• MDR Report Key: 6802523
• Date Received: 2017-08-17
• Date of Report: 2017-08-16
• Date Added to Maude: 2017-08-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 200 BOSTON AVE SUITE 1100
• Manufacturer City: MEDFORD MA 021554288
• Manufacturer Country: US
• Manufacturer Postal: 021554288
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SERI SURGICAL SCAFFOLD
• Generic Name: SERI SURGICAL SCAFFOLD
• Product Code: OXF
• Date Received: 2017-08-17
• Model Number: UNK
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SOFREGEN MEDICAL, INC
• Manufacturer Address: US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-08-17