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); Cellulitis (1768); Ecchymosis (1818); Edema (1820); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Discharge (2225)

Event Date 02/28/2014

Event Type  Injury  

Event Description

Physician reported "spotting where the wound is.Later the spotting turned to redness" on (b)(6) 2014.The patient started antibiotics.On (b)(6) 2014, the "wound opened, scaffold's area is red and purple." the physician indicated the "subject may have an allergy." on (b)(6) 2014, physician reported "bilateral redness in lower poles, without fever, restricted to skin overlying both scaffolds." the physician also noted "swelling" in the same area of redness of the breasts.Patient was admitted to the hospital, and had surgery on (b)(6) 2014 where the device was explanted.Fluid cultured was "positive for staphylococcus epidermis.".

Manufacturer Narrative

Allergan has received the product, however, the analysis has not been completed at this time.The event of erythema, edema, wound dehiscence, ecchymosis, infection, and allergic reaction are surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Manufacturer Narrative

Medwatch sent to fda on 04/27/2016.

Event Description

Physician reported "spotting where the wound is.Later the spotting turned to redness" on (b)(6) 2014.The patient started antibiotics.On (b)(6) 2014, the "wound opened, scaffold's area is red and purple".The physician indicated the ¿subject may have an allergy".On (b)(6) 2014, physician reported ¿bilateral redness in lower poles, without fever, restricted to skin overlying both scaffolds".The physician also noted "swelling" in the same area of redness of the breasts.Patient was admitted to the hospital, and had surgery on (b)(6) 2014 where the device was explanted.Fluid cultured was "positive for staphylococcus epidermis." follow up report from physician indicated the redness and swelling was determined to be cellulitis.Physician also noted "discharge.".

• 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: 3763452
• MDR Text Key: 4552720
• Report Number: 3008374097-2014-00018
• 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: 03/09/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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 SILLICONE GEL FILLED BREAST IMPLANT; EXPLANTED:; IMPLANTED:; IMPLANTED:; 410 COHESIVE SILLICONE GEL FILLED BREAST IMPLANT; EXPLANTED:
• Patient Outcome(s): Required Intervention
• Patient Sex: Female