MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Seroma (2069); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Article citation: quantitative assessment and risk factors for nipple¿areolar complex malposition after nipple-sparing mastectomy.¿ the article was published in breast cancer.The events of seroma, infection, and exposure are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for the events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: postoperative hematoma and seroma may be minimized by meticulous attention to hemostasis during surgery, and possibly by postoperative use of closed drains.Persistent, excessive bleeding must be controlled before the tissue expander is placed.If the wound is stable the tissue expander may be filled to tissue tolerance at the time of surgery to help minimize serous fluid accumulation in the surrounding pocket.If wound stability is a concern, inflate only slightly to fill the pocket space, without applying tension to the tissue.3.Infection pre-existing infections not resolved before tissue expander placement may increase the risk of periprosthetic infection.Infection is an inherent risk following any type of invasive surgery, and may occur during the tissue expansion process.Patients who present with wound dehiscence, tissue erosion, ischemia or necrosis, and patients undergoing immediate breast reconstruction run an increased risk of periprosthetic infection.Signs of acute infection reported in association with tissue expanders include erythema, tenderness, fluid accumulation, pain and fever.Erythema may also occur as a normal response to expansion.Aspiration to differentiate between this type of erythema and erythema as a sign of early infection is a recognized precaution.Research identifies staphylococcus and pseudomonas organisms in association with infection around tissue expanders.Escherichia and streptococcus organisms have also been noted in association with tissue expanders in the lower extremities.Infection may occur at any time after surgery, and may compromise the expansion process.Capsular contracture may be related to infection in the area surrounding the implant.Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications.Infection that is unresponsive to treatment or necrotizing infection may require premature breast tissue expander removal.In rare instances, acute infection may occur in a breast with implants.The signs of acute infection include erythema, tenderness, fluid accumulation, pain, and fever.Very rarely, toxic shock syndrome, a potentially life- threatening condition, has been reported in women after breast implant surgery.It is characterized by symptoms that occur suddenly and include high fever (102°f, 38.8°c or higher), vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should be advised to contact a physician immediately for diagnosis and treatment for any of these symptoms.5.Hematoma/seroma postoperative hematoma and seroma may contribute to infection.Postoperative hematoma and seroma may be minimized by meticulous attention to hemostasis during surgery, and possibly by postoperative use of closed drains.Persistent, excessive bleeding must be controlled before the device is implanted.

Event Description

Reported event of unknown side ¿nipple¿areolar complex malposition,¿ ¿seroma,¿ ¿infection,¿ ¿exposure¿ for patients implanted with ¿textured expanders¿ were noted in quantitative assessment and risk factors for nipple¿areolar complex malposition after nipple-sparing mastectomy.¿ the article was published in breast cancer.¿exposure¿ was treated by additional surgery.Treatment for ¿malposition,¿ ¿seroma,¿ and ¿infection¿ were not specified, and the expander was removed.The manufacturer of the expander is unknown.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): UNKNOWN MANUFACTURER
• Manufacturer (Section G): UNKNOWN MANUFACTURER
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7802989
• MDR Text Key: 117795493
• Report Number: 9617229-2018-06639
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• 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
• Patient Outcome(s): Required Intervention