MAUDE Adverse Event Report: ALLERGAN / LIFECELL ALLODERM; MESH, SURGICAL, POLYMERIC

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Date 02/24/2017

Event Type  Injury  

Event Description

Bilateral mastectomies with immediate reconstruction with alloderm sling.Radiation to cancer side, 16 months with expanders, pain entire time.Four weeks after exchange surgery "infection" to cancer side, 5 days in hosp with iv abx.C-diff infection due to abx.Still with pain.Fat grafting to both resulting in seroma / hematoma to cancer side leading to implant removal.Once removed my ps found the alloderm had not "taken" and was bunched up and rolled, see below.Pain now improved- taking lexapro with good results.I think i will contact the fda.Fda safety report id# (b)(4).

• Brand Name: ALLODERM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ALLERGAN / LIFECELL
• MDR Report Key: 8483003
• MDR Text Key: 141022950
• Report Number: MW5085578
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability