SOLESTA INJECTABLE GEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-06 for SOLESTA INJECTABLE GEL manufactured by Bausch + Lomb.

Event Text Entries

[110280035] Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[110280036] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009443653-2018-00013
MDR Report Key7575139
Report SourceHEALTH PROFESSIONAL
Date Received2018-06-06
Date of Report2018-05-09
Date Mfgr Received2018-05-09
Device Manufacturer Date2016-07-06
Date Added to Maude2018-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. TES PROUD
Manufacturer Street1400 NORTH GOODMAN STREET
Manufacturer CityROCHESTER NY 14609
Manufacturer CountryUS
Manufacturer Postal14609
Manufacturer Phone5853388549
Manufacturer G1Q-MED AB
Manufacturer StreetSEMINARIEGATAN 21
Manufacturer CityUPPSALA 75228
Manufacturer CountrySW
Manufacturer Postal Code75228
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOLESTA INJECTABLE GEL
Generic NameAGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
Product CodeLNM
Date Received2018-06-06
Lot Number14711
ID NumberNI
Device Expiration Date2019-06-30
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer Address1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-06-06

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