MAUDE Adverse Event Report: ALLERGAN UNK SERI SURGICAL SCAFFOLD

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Seroma (2069); Skin Inflammation (2443)

Event Date 02/15/2014

Event Type  Injury  

Event Description

Healthcare professional reported six weeks post implantation of seri and a concomitant unknown mammary device, patient presented with "recurrent redness with no growth from recurrent seromas," implant side unknown.The following week, physician reported patient had an inflammatory reaction from the seri, and subsequently both the concomitant mammary device and seri were explanted.Physician states the events were initially reported for informative purposes and not as a formal complaint against the seri device due to the patient being the physician's first patient implanted with seri.

Manufacturer Narrative

The device availability for return is unknown.Therefore, allergan may not receive it and no analysis or testing may be done.The events of irritation/inflammation, seroma, and erythema are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding the event and product details has been requested.No additional information is available at this time.Physician does not consider the events as a complaint against the device, however these events are being reported as surgical intervention was required.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd.; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3783947
• MDR Text Key: 14881673
• Report Number: 3008374097-2014-00026
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2014

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?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/15/2014
• 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: EXPLANT:; CONCOMITANT UNK MAMMARY DEVICE; IMPLANT:
• Patient Outcome(s): Required Intervention