MAUDE Adverse Event Report: SALIX PHARMACEUTICALS, INC SOLESTA; AGENT, BULKING, INJECTABLE

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

Patient Problems Fever (1858); Pain (1994); Chills (2191)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

The event investigation is underway; a follow up report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient underwent treatment with solesta, on her drive home the patient experienced pain, swelling, fever and vomit.The patient was treated with augmentin (dosage and start date unknown).One week post treatment, the patient continued having cramps, chills and feels dizzy.The patient stated that she was not given an enema before the procedure and had a bowel movement shortly after the procedure.The patient declined to provide any other information.

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) review 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): SALIX PHARMACEUTICALS, INC; rochester NY 14609
• Manufacturer (Section G): Q-MED AB; q-med ab, seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5106085
• MDR Text Key: 26822473
• Report Number: 3009325614-2015-00031
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Followup
• Report Date: 08/28/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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
• Patient Age: 61 YR
• Patient Weight: 64