GALAFORM 3D 100043-02 FR3D02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-10 for GALAFORM 3D 100043-02 FR3D02 manufactured by Tepha, Inc.

Event Text Entries

[119643923] The physician reported that he did not feel that the device led to the infection, and that it was the incision itself that caused the infection. However, because the device may have contributed to the infection, the manufacturer is reporting out of an abundance of caution. As the manufacturer was not made aware in a timely manner, no analysis or testing can be done. Current device labeling addresses the reported event as follows: "possible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. "
Patient Sequence No: 1, Text Type: N, H10


[119643924] Physician reported that in up to three breast surgeries (one mastopexy and two breast reductions) performed in the preceding months and in which he used galaform 3d, he observed redness/rash with infection. The issue was seen as wound dehiscence at the t-junction of the wound closure and followed the line of the product rim. Debridement was performed with a portion of the mesh removed, and the events resolved without sequelae.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005670760-2018-00001
MDR Report Key7859395
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-09-10
Date of Report2018-08-30
Date Mfgr Received2018-04-28
Device Manufacturer Date2017-05-08
Date Added to Maude2018-09-10
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 ContactMRS BARBARA RINALDI
Manufacturer Street99 HAYDEN AVE SUITE 360
Manufacturer CityLEXINGTON MA 02421
Manufacturer CountryUS
Manufacturer Postal02421
Manufacturer Phone7813571758
Manufacturer G1TEPHA, INC
Manufacturer Street99 HAYDEN AVE SUITE 360
Manufacturer CityLEXINGTON MA 02421
Manufacturer CountryUS
Manufacturer Postal Code02421
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGALAFORM 3D
Generic NameSURGICAL SCAFFOLD
Product CodeOOD
Date Received2018-09-10
Model Number100043-02
Catalog NumberFR3D02
Lot Number170166
Device Expiration Date2018-04-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTEPHA, INC
Manufacturer Address99 HAYDEN AVE SUITE 360 LEXINGTON MA 02421 US 02421


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-09-10

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