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.
[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
| 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 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-27 |