MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fever (1858); Pneumonia (2011); Ulceration (2116)

Event Type  Injury  

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Thrombocytopenia [thrombocytopenia].Disease progression [disease progression].Pneumonia [pneumonia].Abdominal pain [abdominal pain].Pyrexia [pyrexia].Decreased appetite [decreased appetite].Mouth ulceration [mouth ulceration].Stomatitis [stomatitis].Case description: initial information received on 10-nov-2016: this spontaneous medical device report was received from a literature article by sukeepaisarnjaroen w.Et al., entitled "results of tracer - phase ii randomized, double-blinded, multicentre asian study investigating the combination of transcatheter arterial chemoembolization (tace) and oral everolimus in localised unresectable hepatocellular carcinoma (hcc)" published in the liver cancer journal concerning 33 patients of asian ethnicity of unknown age and gender.The patients' medical history included newly diagnosed, localized unresectable hcc (time since initial diagnosis

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Thrombocytopenia, disease progression, pneumonia, abdominal pain, pyrexia, decreased appetite, mouth ulceration, stomatitis.Case description: initial information received on 10-nov-2016: this spontaneous medical device report was received from a literature article by sukeepaisarnjaroen w.Et al., entitled "results of tracer - phase ii randomized, double-blinded, multicentre asian study investigating the combination of transcatheter arterial chemoembolization (tace) and oral everolimus in localised unresectable hepatocellular carcinoma (hcc)" published in the liver cancer journal concerning 33 patients of asian ethnicity of unknown age and gender.The patients' medical history included newly diagnosed, localized unresectable hcc (time since initial diagnosis

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Thrombocytopenia.Disease progression.Pneumonia.Abdominal pain.Pyrexia.Decreased appetite.Mouth ulceration.Stomatitis.Case description: initial information received on 10-nov-2016: this spontaneous medical device report was received from a literature article by sukeepaisarnjaroen w.Et al., entitled "results of tracer - phase ii randomized, double-blinded, multicentre asian study investigating the combination of transcatheter arterial chemoembolization (tace) and oral everolimus in localised unresectable hepatocellular carcinoma (hcc)" published in the liver cancer journal concerning 33 patients of asian ethnicity of unknown age and gender.The patients' medical history included newly diagnosed, localized unresectable hcc (time since initial diagnosis

• Brand Name: DC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 1252 732 7
• MDR Report Key: 6124139
• MDR Text Key: 60841757
• Report Number: 3002124545-2016-00069
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other