EPICEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-02 for EPICEL manufactured by Genzyme Biosurgery Cambridge.

Event Text Entries

[4765077] This unsolicited device case from united states was received on (b)(6) 2014 from a healthcare professional. This case concerns a male pt (age not provided) who developed squamous cell carcinoma after grafting with epicel cultured epidermal autografts (epicel). No medical history, past drugs, concomitant medications and concurrent conditions were reported. On an unk date, the pt suffered 95% total body surface area burn. On (b)(6) 1998, the pt was grafted with epicel cultured epidermal autografts once (route, formulation, batch/lot number and expiration date: unk) on an unspecified location for thermal burn. On an unk date in (b)(6) 2011, the pt developed a non-healing ulcer on his left posterior lateral knee. Later biopsy was performed and it revealed a well differentiated squamous cell carcinoma. The wound was excised and successfully healed with autografts. It was reported that the pathology confirmed clear margins and no recurrences were seen till date. Corrective treatment: wound excision and autografts. Outcome: recovered. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criterion: important med event. Additional info was received on (b)(6) 2014 from the physician. The pt's initials were added. The suspect therapy start date was provided. The biopsy details were provided. The outcome of the event updated from unk to recovered. Corrective treatment updated. Clinical course updated and text amended accordingly. Pharmacovigilance comment: sanofi co comment for follow up dated (b)(6) 2014: follow up received does not change previous case assessment. Sanofi co comment dated (b)(6) 2014: this case concerns a pt who developed squamous cell carcinoma after receiving epicel cultured epidermal auto grafts for thermal burns. Although the role of device cannot be ruled out based on the device event temporal relationship, lack of detailed info about medical history, lab data, any concurrent med illnesses, clinical course etc. Of the pt precludes a comprehensive assessment in this case.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1226230-2014-31512
• MDR Report Key: 4147262
• Report Source: 05
• Date Received: 2014-10-02
• Date Mfgr Received: 2014-09-17
• Date Added to Maude: 2014-10-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KRISTEN SHARMA, MD
• Manufacturer Street: 55 CORPORATE DRIVE 55C-235A
• Manufacturer City: BRIDGEWATER NJ 08807
• Manufacturer Country: US
• Manufacturer Postal: 08807
• Manufacturer Phone: 9089812784
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPICEL
• Generic Name: CULTURED EPIDERMAL AUTOGRAFTS
• Product Code: OCE
• Date Received: 2014-10-02
• Operator: HEALTH PROFESSIONAL
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GENZYME BIOSURGERY CAMBRIDGE
• Manufacturer Address: CAMBRIDGE MA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-10-02