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

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Event Description

(b)(6) year old female reported that she received solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal as treatment for fecal incontinence following a birthing tear seven years ago.Add'l medical history included solesta treatment in (b)(6) 2013 with no problems.Concurrent medications were not provided.On (b)(6) 2014, the pt received four injections of solesta.Following injections, the pt experienced mild bleeding described as "bright red spotting".Especially when she had a bowel movement.On (b)(6) 2014, the pt experienced pain in the injections area with the pain/soreness increasing on (b)(6) 2014.From the evening of(b)(6) 2014.From the evening of (b)(6) 2014 to early morning (b)(6) 2014, the pt was unable to sleep due to the pain.She took four ibuprofen tablets, 200 mg each, with only mild relief.The pt had contacted the on-call physician and was told to alternate ibuprofen and acetaminophen to control the pain.No relief from this measure resulted.At the time of this report, the pt was considering going to the emergency room.Outcome for the events was unk.A separate report was received from a nurse via a sales rep.In speaking with the nurse, the pt contacted the on-call physician on (b)(6) 2014 who then contacted the pt's treating physician.On (b)(6) 2014, the pt was admitted to the emergency room where a "sizeable" perirectal abscess was drained.This was performed as an outpatient procedure and the pt was subsequently discharged.The pt had a follow up visit scheduled for (b)(6) 2014 and the events were considered resolving at the time of this report.The nurse felt the events were serious as they required surgical intervention.She did not feel the events were related to solesta because the physician had told her that there were 4 perfect wheals at the time of solesta injection.Additionally, she felt the cause of the abscess might have been due to the pt's very serious abnormal structures as a result of her past history of birthing trauma.The pt had undergone a few surgical repairs in the past.

Manufacturer Narrative

The report concerns a pt who received solesta and developed a perirectal abcess which was drained in the hosp as an outpatient procedure.The case had been assessed as unrelated by reporting nurse.As mfr we consider the injection procedure per se as a potential contributing factor and can therefore not totally exclude a possible causality.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer (Section G): SALIX PHARMACEUTICALS INC.; 8510 colonnade center dr; raleigh NC 27615
• Manufacturer Contact: seminarigetan 21; uppsala SE-75-2 28
• MDR Report Key: 3931551
• MDR Text Key: 19968164
• Report Number: 3009325614-2014-00034
• 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: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• 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 Manufacturer Received: 05/24/2014
• 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 Age: 44 YR