MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL GMBH ALLODERM MESH; MESH, SURGICAL, POLYMERIC

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2012

Event Type  Injury  

Event Description

Alloderm mesh post 7 years implanted in reconstructive breast surgery began to shrink.Emergency surgery to remove.Fda safety report id# (b)(4).

• Brand Name: ALLODERM MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL GMBH
• MDR Report Key: 15499251
• MDR Text Key: 300992476
• Report Number: MW5112314
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White