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

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/19/2015

Event Type  Injury  

Event Description

Healthcare professional reported implantation of seri surgical scaffold and concomitant breast implant on (b)(6) 2014 during right side mastectomy reconstruction.Post-implantation, on (b)(6) 2015, the patient presented with an open wound on the right breast revealing the seri device.Wound was excised, and the device was removed and discarded.Healthcare professional reported "seri non integrated, bunched up under skin, created wound.".

Manufacturer Narrative

Unique identifier (udi)#: not applicable.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of inadequate tissue ingrowth and exposure are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive it, and no analysis or testing will be done.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: krista alvarado ; 301 w. howard lane, suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4877610
• MDR Text Key: 21085923
• Report Number: 3008374097-2015-00048
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2015

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: 05/29/2015
• Initial Date FDA Received: 06/26/2015
• 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: STYLE FF410-335 SILICONE BREAST IMPLANT; PATIENT IMPLANTED WITH CONCOMITANT ALLERGAN
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR