MAUDE Adverse Event Report: ALLERGAN UNK SCAFFOLD

Catalog Number UNK SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fluid Discharge (2686)

Event Date 01/26/2015

Event Type  Injury  

Event Description

Health professional reported implantation os seri surgical scaffold and concomitant breast implant during left side mastopexy surgery.Post-implantation, the pt experienced implant exposure with drainage and the "seri did not incorporate".Treatment included removal of the breast implant.It is unk whether the seri surgical scaffold remains implanted.The device is not available for return.

Manufacturer Narrative

Further info from the reporter regarding event, prod and pt details has been requested.No add'l info is available at this time.The events of exposure, drainage and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining the probable cause of these events.These events are being reported because medical intervention was required, although device-relatedness has not been established.

• Brand Name: UNK SCAFFOLD
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: krista alvarado ; 301 w howard lane; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4548806
• MDR Text Key: 5517040
• Report Number: 3008374097-2015-00015
• 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: 01/26/2015

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 SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 02/24/2015
• 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
• Treatment: ALLERGAN STYLE 410 BREAST IMPLANT
• Patient Outcome(s): Required Intervention