RESTORELLE - UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-27 for RESTORELLE - UNKNOWN manufactured by Coloplast A/s.

Event Text Entries

[186150862] It was reported the patient also had a supris device implanted. The supris is registered under 2125050-2020-00268. (b)(4). Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10


[186150863] As reported to coloplast though not verified, the patient's legal representative stated the patient suffered complications including severe pelvic pain, urinary and voiding problems, incontinence, difficulty with daily activities, suffered and continues to suffer multiple severe and painful personal injuries, including but not limited to urinary incontinence, physical deformity, and the loss of the ability to perform sexually. A revision surgery on (b)(6) 2018 was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2125050-2020-00267
MDR Report Key9890112
Report SourceOTHER
Date Received2020-03-27
Date of Report2020-03-23
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE PERRYMAN
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1COLOPLAST MANUFACTURING US, LLC
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESTORELLE - UNKNOWN
Generic NameSURGICAL MESH
Product CodeOTO
Date Received2020-03-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOLOPLAST A/S
Manufacturer AddressHOLTEDAM 1 HUMLEBAEK, 3050 DA 3050


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-27

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