MAUDE Adverse Event Report: ALLERGAN ALLERGAN/NATRELLE; TISSUE EXPANDER

Model Number MSZMF580

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/13/2015

Event Type  Injury  

Event Description

Physician requested implants to be sent back to manufacturer.He stated this isn't the first time this has happened with this same product.

• Brand Name: ALLERGAN/NATRELLE
• Type of Device: TISSUE EXPANDER
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4888112
• MDR Text Key: 6018679
• Report Number: MW5043440
• Device Sequence Number: 1
• Product Code: LCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2019
• Device Model Number: MSZMF580
• Device Lot Number: 19440910
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 63