MAUDE Adverse Event Report: BAUSCH + LOMB SOLESTA; AGENT, BULKING, INJECTABLE

Model Number SOLESTA

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

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

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

The consumer reported a rectal mass that is starting to bulge into the vaginal wall approximately one and a half years post solesta injection.Reportedly, the mass was noted one month after injection, but no symptoms were reported.The consumer reported seeking second opinion for consideration of secondary procedure to remove said mass.Additional information has been requested, but has not been received.

Manufacturer Narrative

The device was not returned to b+l for evaluation; therefore, product evaluation could not be conducted.The lot number of the device was not provided; therefore, a batch record review (brr)could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively determined.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): Q-MED, SEMINARIEGATAN 21; q-med, seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5629417
• MDR Text Key: 44330867
• Report Number: 3009443653-2016-00007
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

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: Physician
• Device Model Number: SOLESTA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• 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