MAUDE Adverse Event Report: GENZYME CORPORATION SEPRAFILM SLURRY; BARRIER, ABSORBABLE, ADHESION

Device Problem Nonstandard Device (1420)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Deformity/ Disfigurement (2360)

Event Date 08/24/2012

Event Type  Injury  

Event Description

Seprafilm slurry by genzyme was implanted at the time of hysterectomy in 2010.I developed complications immediately after discharge.I was re-admitted several times for ongoing complications.Ongoing complications and debilitating pain caused ongoing pelvic surgeries.I'm permanently disabled/bedridden and suffer from unmanaged severe intractable pelvic pain.Pathology and op-reports confirmed poor wound health, chronic inflammation, adhesions and fluid caused by adverse effects.Thick glue type substances found throughout abdominal/pelvic cavity glued all organs together.The hospital or surgeon never disclosed seprafilm slurry was implanted.I was never notified of the recall.I found out after google what seprafilm slurry was.I've been told my tissue is mutilated beyond repair.Pain management is the only option to improve function and qol.Unfortunately, pain management is denied because of cdc & dea guidelines.Denying rx to a patient who suffers from severe intractable pain is inhumane and cruel.Relentless, debilitating pain is no way to live.I no longer am able to complete basic tasks or care for myself.Had the healthcare system not failed me countless times i wouldn't be in this situation.I need help asap.Op-reports and pathology reports.

• Brand Name: SEPRAFILM SLURRY
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 15958911
• MDR Text Key: 305277184
• Report Number: MW5113717
• Device Sequence Number: 1
• Product Code: MCN
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Disability
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White