SUPERCUT FREEMAN SCS 7 CVD 102229

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-27 for SUPERCUT FREEMAN SCS 7 CVD 102229 manufactured by Integra Gmbh.

Event Text Entries

[3036468] The customer initially reported that the black supercut handles are beginning to smudge and come off on the surgeon's gloves. Including a cloth that shows the black smudges from the ring handles. On (b)(6) 2012, customer reports the surgeon was performing a facelift procedure when this occurred and surgeon was concerned about what the effects of this residue would be on the pt.
Patient Sequence No: 1, Text Type: D, B5

[10211014] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

Report Number	2523190-2012-00080
MDR Report Key	2773250
Report Source	06
Date Received	2012-09-27
Date of Report	2012-09-27
Date Mfgr Received	2012-09-21
Date Added to Maude	2013-01-16
Event Key	0
Report Source Code	Manufacturer report
Manufacturer Link	Y
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Manufacturer Contact	SANDRA LEE
Manufacturer Street	315 ENTERPRISE DRIVE
Manufacturer Country	US
Manufacturer Phone	6099366828
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Details

Brand Name	SUPERCUT FREEMAN SCS 7 CVD
Generic Name	NONE
Product Code	HRR
Date Received	2012-09-27
Catalog Number	102229
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	DA
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	INTEGRA GMBH
Manufacturer Address	RATINGEN 40880 40880

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-27