MATRISTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-13 for MATRISTEM manufactured by Acell.

Event Text Entries

[80306465] Mesh erosion/exposure after davinci assisted laparoscopic sacrocolpopexy using acell (pig mesh) in (b)(6) 2013; remains unresolved despite conservative treatment and multiple office excisions of exposed mesh; unable to have intercourse for over a year now; continue to have prolapse despite mesh (i. E. Failure to treat the problem).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071015
MDR Report Key6717756
Date Received2017-07-13
Date of Report2017-07-13
Date of Event2014-07-01
Date Added to Maude2017-07-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMATRISTEM
Generic NameMESH, SURGICAL
Product CodeKGN
Date Received2017-07-13
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerACELL


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-07-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.