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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Abscess (1690); Discomfort (2330); Malaise (2359)

Event Date 05/08/2014

Event Type  Injury  

Event Description

A nurse reported via a sales representative that a (b)(6) female received solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal as treatment for fecal incontinence.Additional medical history included prior solesta injection in (b)(6) 2013 without problems.Concurrent medications were not provided.On (b)(6) 2014, the patient received solesta.On (b)(6) 2014, the patient was being evaluated in her physician's office for a burning sensation in her rectum and "not feeling well" which resulted in the patient having "trouble getting out of bed".Based on the subjective complaints, the physician suspected a possible abscess.The patient was sent for a computed tomography scan and blood work.She was diagnosed with a perirectal abscess and hospitalized.An incision and drainage was performed.On (b)(6) 2014, the patient was discharged with the drain still in place.As of (b)(6) 2014, the patient was recovering and the drain remained intact.Causality was not provided.The company assessed the events as possibly related to solesta.

Manufacturer Narrative

Based on the information, a causality seems possible.Since the patient was hospitalized and treated with incision and drainage of a perirectal abscess the case fulfills the criteria for regulatory reporting.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3874135
• MDR Text Key: 16778380
• Report Number: 3009325614-2014-00033
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2014,05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Distributor Facility Aware Date: 05/08/2014
• Date Report to Manufacturer: 05/22/2014
• Date Manufacturer Received: 05/08/2014
• 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): Required Intervention
• Patient Age: 62 YR