MAUDE Adverse Event Report: ALLERGAN (MEDFORD) UNK SERI SURGICAL SCAFFOLD; MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 10/17/2015.No contact information for the patient or the patient's physician was provided.Additional event, product, or patient details are not attainable at this time.The event of infection is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.No information was provided on the current status of the device.No analysis or testing has been completed at this time because the device has not been returned.Device labeling addresses the reported event of infection as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion." these events are being reported because medical intervention was required, although device-relatedness has not been established.

Event Description

Acquaintance of patient reported via voluntary submission to fda, mw5045045, patient experienced an infection after implantation with seri® surgical scaffold during an unknown mammoplasty procedure.This record is for the left side seri® scaffold.

Manufacturer Narrative

Medwatch sent to fda on 12/9/2015.Corrected data: the previously submitted report indicated the report was sent on 10/17/2015.The correct date of submission was 11/17/2015.

Event Description

Acquaintance of patient reported via voluntary submission to fda, mw5045045, patient experienced an infection after implantation with seri surgical scaffold during an unknown mammoplasty procedure.This record is for the left side seri scaffold.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer (Section G): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer Contact: krista alvarado ; 301 w howard lane; suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 5230541
• MDR Text Key: 31414830
• Report Number: 8020862-2015-00035
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SERI SURGICAL SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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