HP TISSUE MATRIX HPTM 08161097

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-01 for HP TISSUE MATRIX HPTM 08161097 manufactured by Lifecell.

Event Text Entries

[46889453] Developed a staph infection of either the breast expander or the hptm by lifecell. I noticed in my record that the dermal matrix was in trial. I did not give any permissions to be in a trial. Dermal matrix and implants were removed due to a staph infection (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062726
MDR Report Key5707009
Date Received2016-06-01
Date of Report2016-06-01
Date of Event2015-08-05
Date Added to Maude2016-06-08
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 NameHP TISSUE MATRIX
Generic NameHP TISSUE MATRIX
Product CodeOXH
Date Received2016-06-01
Model NumberHPTM
Catalog Number08161097
Lot NumberUP100005-026
Device Expiration Date2015-09-30
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLIFECELL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2016-06-01

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