MAUDE Adverse Event Report: BAUSCH + LOMB SOLESTA INJECTABLE GEL; AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE

Model Number SOLESTA

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of this investigation.

Event Description

Reportedly the patient had an anal mass removed a few years post dextranomer/hyaluronic acid (dx/ha) injection.Pathologist believed that the removed mass is the injected gel migrated from the initial point of injection.The details of the surgery were not provided.Additional information regarding this event was requested but not received.

Manufacturer Narrative

The product was not returned for evaluation.Due to the unknown lot number, device history records could not be reviewed.Additional attempts to get more information about this incident were unsuccsessful.Based on the available information the root cause of the this incident is unknown.

• Brand Name: SOLESTA INJECTABLE GEL
• Type of Device: AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7051380
• MDR Text Key: 92738605
• Report Number: 3009443653-2017-00040
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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
• Device Model Number: SOLESTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 04/13/2018
• 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): Other