MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Ischemia (1942); Seroma (2069)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Article citation: ¿risk factors for capsular contracture: a retrospective study in immediate reconstruction versus delayed reconstruction;¿ maiko de kerckhove, md, phd, yoshiko iwahira, md, phd; wolters kluwer health inc.; prs global open 2020; 21 may 2020; the american society of plastic surgeons 2020.(b)(4).The events of seroma, infection (unknown onset), ischemia, wound dehiscence, necrosis, exposure and capsular contracture are 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 event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: seroma, infection (unknown onset), ischemia, wound dehiscence, necrosis, exposure and capsular contracture grade iii-iv.

Event Description

Journal article ¿risk factors for capsular contracture: a retrospective study in immediate reconstruction versus delayed reconstruction¿ reported complications following delayed ¿expander insertion¿ of ¿hematoma, seroma, infection, ischemic skin wound, exposure occurrence.¿ patient was considered to experience hematoma ¿if history of hematoma removal or a subcutaneous hemorrhage beyond the dissection area¿ and skin ischemia ¿judged to be present in the case of necrosis or dehiscence of the wound margin or nipple areola regions.¿ baker grade iii or iv was diagnosed for all patients with capsular contracture formation.The tissue expander was explanted after 7 months.Events occurred on an unknown side.This record captures the 27 patients with an allergan expander where surgery was delayed.The event of hematoma is deemed to be not related to the device.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10986587
• MDR Text Key: 220770733
• Report Number: 9617229-2020-20583
• 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: Other
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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
• Date Manufacturer Received: 11/11/2020
• 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: CHEMOTHERAPY, HORMONE THERAPY, AND RADIATION
• Patient Outcome(s): Required Intervention