MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-12-01 for FUTURA SAFETY SCALPEL 68001 manufactured by Futura Medical Products (p) Ltd.
[431723]
Customer indicated that the springs are coming out and the area where the node that keeps the scalpel in place is coming apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832816-2005-00036 |
| MDR Report Key | 649661 |
| Report Source | 08 |
| Date Received | 2005-12-01 |
| Date of Report | 2005-11-04 |
| Date of Event | 2005-11-04 |
| Date Mfgr Received | 2005-11-14 |
| Date Added to Maude | 2005-12-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUCE MACFARLANE |
| Manufacturer Street | 5182 W 76TH STREET |
| Manufacturer City | EDINA MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9526463188 |
| Manufacturer G1 | FUTURA MEDICAL PRODUCTS (P), LTD. |
| Manufacturer Street | PLOT#7 COCHIN SPECIAL ECONOMIC ZONE |
| Manufacturer City | KAKKANAD, KOCHI 682030 |
| Manufacturer Country | IN |
| Manufacturer Postal Code | 682 030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURA SAFETY SCALPEL |
| Generic Name | SAFETY SCALPEL |
| Product Code | GDX |
| Date Received | 2005-12-01 |
| Model Number | 68001 |
| Catalog Number | 68001 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 639151 |
| Manufacturer | FUTURA MEDICAL PRODUCTS (P) LTD |
| Manufacturer Address | * KAKKANAD IN |
| Baseline Brand Name | FUTURA SAFETY SCALPEL |
| Baseline Generic Name | SAFETY SCALPEL |
| Baseline Model No | 68001 |
| Baseline Catalog No | 68001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-01 |