MAUDE Adverse Event Report: Q-MED AB SOLESTA; AGENT, BULKING, INJECTABLE

Lot Number 11873-1

Device Problem Shelf Life Exceeded (1567)

Patient Problems Sepsis (2067); Septic Shock (2068); Chills (2191)

Event Date 08/06/2014

Event Type  Injury  

Event Description

A pharmacist and a colorectal surgeon reported that an (b)(6) y/o male received solesta (dextranomer/ hyaluronic acid) injection into the submucosa of the anal canal as treatment for fecal incontinence.Add'l medical history included an enlarged prostate.Concurrent medications were not provided.On (b)(6) 2014, in the afternoon, the pt received solesta.Antibiotics were not administered prior to solesta injection.On (b)(6) 2014, around 1000 to 1100, the pt's daughter discovered her father with rigors.The pt was subsequently admitted to the intensive care unit at the hospital with escherichia coli bacteremia.He was in septic shock and administered intravenous antibiotics and a norepinephrine drip.The pt was improving following treatment.It was believed, but not confirmed, that the pt had been discharged at the time of this report.Expiration date for the device was jun 2014 (device expired).The physician felt the events were life-threatening and related to the use of solesta given the timing of the injection and rapid development of the sepsis.The company felt the events were related to solesta.

Manufacturer Narrative

The medical history (enlarged prostate) and the treatment per se may have contributed to the events.In addition, the pt is (b)(6) yrs.A detailed medical history is not provided.It is possible that the pt may have other medical conditions that predispose him to bacteremia (e.G.Pneumonia or urinary tract infection).In the instructions for use solesta, it is recommended that antibiotics are administered prior to injection.Furthermore, it is not recommended to use a device after the expiration date.A trend analysis shows that there are no increased trends of medical complaint for the reported lot number of (b)(4).

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala SE-7 52 2; SW SE-752 28
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4129699
• MDR Text Key: 4948677
• Report Number: 3009325614-2014-00042
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2014,08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 11873-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2014
• Distributor Facility Aware Date: 08/07/2014
• Date Report to Manufacturer: 08/22/2014
• Date Manufacturer Received: 08/07/2014
• 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): Hospitalization; Life Threatening
• Patient Age: 85 YR