MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	133MV-13
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling: patients should be advised that the tissue expanders may deflate, and require replacement surgery.Deflation occurs when saline leaks through a damaged injection site or a damaged tissue expander envelope.
Event or Problem Description
Healthcare professional reported a tissue expander "would not fill properly," and, "the valve was separated from the tissue expander pocket." surgery was completed with a backup device.Patient contact did not occur.
Additional Manufacturer Narrative
Device analysis: a leak test was performed and found no openings.A microscopic analysis of the returned device identified the device is intact and functional.Based on the device analysis the final assessment is: the device is intact and functional no observations found related with the complaint reported by the physician.
Event or Problem Description
Healthcare professional reported a tissue expander "would not fill properly," and, "the valve was separated from the tissue expander pocket." surgery was completed with a backup device.Patient contact did not occur.

• Brand Name: STYLE 133MV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7812810
• Report Number: 9617229-2018-06653
• Device Sequence Number: 2337698
• Product Code: LCJ
• UDI-Device Identifier: 10888628004122
• UDI-Public: 10888628004122
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 133MV-13
• Device Lot Number: 3121216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other