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

Lot Number 14711

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

Patient Problems Cyst(s) (1800); Reaction, Injection Site (2442)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient was hospitalized for 5 days after receiving a solesta injection due to a reaction and a cyst.The patient alleged that he "probably had an ulcer that never manifested itself but solesta exacerbated it" and that this probably occurred from straining while attempting to have a bowel movement.The patient is said to be making an appointment with a doctor.Additional information was requested, but has not been received.

Manufacturer Narrative

The device was not available for return.A device history record (dhr) review did not find nonconformities or anomalies related to this complaint.Based on the available information, a root cause for the reported event could not be conclusively determined.

• 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
• MDR Report Key: 7575139
• MDR Text Key: 110280035
• Report Number: 3009443653-2018-00013
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): Y
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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 Expiration Date: 06/30/2019
• Device Lot Number: 14711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR