MAUDE Adverse Event Report: ALLERGAN (MEDFORD) 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 Problems Edema (1820); Erythema (1840); Pocket Erosion (2013)

Event Type  Injury  

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 events of redness, swelling, inadequate tissue ingrowth, and a seri® surgical scaffold which ¿expelled itself¿ are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event of ¿a seri® surgical scaffold which ¿expelled itself¿ as follows: ¿adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.¿ the device has not been returned.Therefore, no analysis or testing has been done.

Event Description

Physician reported a patient experiencing redness, swelling, and a seri® surgical scaffold which ¿expelled itself¿.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 6311886
• MDR Text Key: 66817071
• Report Number: 8020862-2017-00001
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

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: 01/13/2017
• Initial Date FDA Received: 02/08/2017
• 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 BREAST IMPLANT
• Patient Outcome(s): Required Intervention