MAUDE Adverse Event Report: ALLERGAN SERISCAFFOLD SURGICAL SCAFFOLD (OUS); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number SCF10X25AEGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Staphylococcus Aureus (2058)

Event Date 12/15/2013

Event Type  Injury  

Event Description

Physician reported left side device removal due to "wound dehiscence due to chemotherapy followed by infection."upon explant, it was noted there was no adherence of the scaffold to the surrounding tissue.".

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.Would dehiscence and infection are surgical/physiological complications and analysis of the devic generally does not assist allergan in determining a probable cause of this event.

Event Description

Follow-up information received from the physician revealed the "infection" was not receive related.This medwatch represents the left side seriscaffold device.

Manufacturer Narrative

Medwatch sent to fda on 05/02/2016.Received additional information from health professional indicating that wound dehiscence is considered not device related.The event of wound dehiscence will be unreported at this time.

Event Description

Additional follow-up information received from the physician confirmed the wound dehiscence was not related to the device.

• Brand Name: SERISCAFFOLD SURGICAL SCAFFOLD (OUS)
• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 3760926
• MDR Text Key: 4482486
• Report Number: 3008374097-2014-00019
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2014

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 Expiration Date: 09/30/2015
• Device Catalogue Number: SCF10X25AEGEN
• Device Lot Number: P12082701B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: 410 COHESIVE SILICONE GEL FILLED BREAST ; EXPLANTED:; EXPLANTED:; 410 COHESIVE SILICONE GEL FILLED BREAST
• Patient Outcome(s): Required Intervention