FDA Adverse Event Injury Summary report: N

SERI SURGICAL SCAFFOLD (US)

MDR report key: 4101676 · Received August 28, 2014

Report

Report Number: 3008374097-2014-00069
Event Type: Injury
Date Received: August 28, 2014
Date of Event: June 9, 2014
Report Date: July 9, 2014
Manufacturer: ALLERGAN
Product Code: OXF
PMA / PMN Number: K123128
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FURTHER INFO FROM THE REPORTER REGARDING THE EVENT AND PRODUCT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF EXTRUSION AND ERYTHEMA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THESE EVENTS ARE BEING REPORTED BECAUSE MED INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED. THIS EVENT IS REPORTED AGAINST THE LEFT SIDE, AND IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID #3008374097-2014-00068 (ALLERGAN COMPLAINT B)(4)).

Description of Event or Problem · 1

HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI WITH A CONCOMITANT SILICONE BREAST IMPLANT ON (B)(6) 2014 DURING REVISION AUGMENTATION SURGERY. POST IMPLANT ON (B)(6) 2014, PT REPORTED LEFT SIDE BREAST REDNESS, IRRITATION, PAIN, AND THE IMPLANT "WENT UP AND FEELS HARD." PHYSICIAN STATED PT WAS PRESCRIBED KEFLEX TO TREAT BREAST REDNESS, HOWEVER, THE EVENT DID NOT RESOLVE. SERI AND CONCOMITANT BREAST DEVICE LATER "EXTRUDED" THROUGH THE SKIN, AND WERE SUBSEQUENTLY FULLY EXPLANTED ON (B)(6) 2014. EXPLANTED SERI DEVICE WAS DESCRIBED AS "YELLOWY" FROM POSSIBLE SEROMA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
526628	SERI SURGICAL SCAFFOLD (US)		OXF	ALLERGAN	NA	P12060401

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention	IMPLANTED WITH A CONCOMITANT SILICONE BREAST\| IMPLANT DATE:\| EXPLANT DATE: