MAUDE Adverse Event Report: ALLERGAN UNK SERI SURGICAL SCAFFOLD

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problems Material Disintegration (1177); Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Erythema (1840); Pain (1994); Seroma (2069)

Event Date 12/24/2013

Event Type  Injury  

Event Description

Company rep reported post-implantation of seri during a "procedure to reposition the pt's [inframammary fold]" after reconstructive surgery, pt presented with "erythema of the skin flap.The distribution of the redness exactly mapped the underlying seri implant.The symptoms were treated conservatively with antibiotics and anti-inflammatory medication.[patient] also experienced tenderness and diffuse soreness of the area.The pt had no antecedent or concurrent infection." additionally, physician drained seromatous "clear, straw coloured" fluid.Physician later examined pt in the operating room and findings included "fibrinous exudates, a 100cc seroma (clear yellow fluid) and a non-adherent seri implant".Seri and mammary device were explanted, and physician noted "that immediately upon pt's emergence from anesthesia.[patient's] soreness and tenderness had fully resolved".

Manufacturer Narrative

Device availability for return is unk, therefore, allergan may not receive it and no analysis or testing may be done.Further info from the reporter regarding the event and product details have been requested.No add'l info is available at this time.The events of seroma, erythema, edema, elevated c-reactive protein.Non adherence, and pain are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3649989
• MDR Text Key: 4283697
• Report Number: 3008374097-2014-00011
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2014

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 Catalogue Number: UNK SERI SURGICAL SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/10/2014
• 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: EXPLANTED ON:; IMPLANTED WITH CONCOMITANT UNK MAMMARY DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR