MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR HYDROGEL; HYDROGEL SPACER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Pain (1994); Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2021

Event Type  Injury  

Event Description

Reporter states he had spaceoar hydrogel implanted in preparation for prostate cancer treatment.He noticed problems immediately, and describes feeling a "rip" during the implant procedure that was painful to the point of "i've never had pain like that in my life.Never." after the procedure, he states that he needed his daughter's help getting to the car because moving was too painful.He did report his experience to the manufacturer at that time.One week later, he sought emergency medical treatment where it was discovered that he was experiencing urinary retention and required catheterization; afterward he had ongoing medical treatment with a urologist.Due to these problems, the radiation treatment for prostate cancer was postponed three months.He states he was unable to sit had to use a heating pad for about six months due to pain and bruising.The spaceoar device was still visible as recently as (b)(6) 2022, when he had a ct scan.Reporter has concerns regarding this device and the adverse events he has experienced and is reporting to the fda accordingly.

• Brand Name: SPACEOAR HYDROGEL
• Type of Device: HYDROGEL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 14359927
• MDR Text Key: 291509740
• Report Number: MW5109638
• Device Sequence Number: 1
• Product Code: OVB
• 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: 05/10/2022

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2022
• Patient Sequence Number: 1
• Treatment: HEATING PAD; URINARY CATHETER
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male