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

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Event Date 04/11/2015

Event Type  Injury  

Event Description

Company representative reported healthcare professional used seri surgical scaffold on a patient and "the seri started to extrude.".

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of extrusion is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Allergan has not received the device at this time.Therefore, no analysis or testing has been done.These events are being reported because medical intervention was required, although device-relatedness has not been established.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer Contact: krista alvarado ; 301 w howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4817890
• MDR Text Key: 21189391
• Report Number: 3008374097-2015-00035
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 06/02/2015
• 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
• Patient Outcome(s): Required Intervention