UPPER MODULE, COM1 201665

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 2019-03-05 for UPPER MODULE, COM1 201665 manufactured by Allergan (dublin).

Event Text Entries

[137872045] Pending investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[137872046] A treatment provider reported that a patient was treated to the upper and lower abdomen, and bilateral flanks, on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018. The patient experienced pain for three months post treatment for which steroids were given. On (b)(6) 2018, the patient presented with nodules under the treated areas. By the time the manufacturer was notified of the event, the pain had subsided. The nodules were described as hard tissue that felt like baseballs, did not emit heat, and did not hurt. Two biopsies were performed and showed fat necrosis. An ultrasound showed tissue reaction to focus trauma and thickening of the tissue related to fat necrosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007215625-2019-00021
MDR Report Key8391899
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-05
Date of Report2019-04-12
Date of Event2018-09-07
Date Mfgr Received2019-03-19
Date Added to Maude2019-03-05
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. JENNIFER CLETO
Manufacturer Street4410 ROSEWOOD DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone9256214130
Manufacturer G1ALLERGAN (DUBLIN)
Manufacturer Street5996 GLEASON DRIVE
Manufacturer CityDUBLIN CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUPPER MODULE, COM1
Generic NameDERMAL COOLING PACK/VACUUM/MASSAGER
Product CodeOOK
Date Received2019-03-05
Catalog Number201665
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (DUBLIN)
Manufacturer Address5996 GLEASON DRIVE DUBLIN CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-05

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