MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-15 for SANDEL HEALTHCARE SAFETY DEVICES 2215-N manufactured by Ansell Sandel Medical Solutions Llc.
[20661150]
(b)(6) healthcare safety devices weighted safety scalpel #3 disposable safety handle with #15 blade reference number 2215-n lot number 1394. Safety handle not locked into place in packaging leaving exposed scalpel blades that punctured sterile packaging. Exposed blades have potential for user injury and have compromised scalpel sterility. Most scalpels in box had this defect and reoccurred in several other boxes of the same lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038258 |
| MDR Report Key | 4109233 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-15 |
| Date Added to Maude | 2014-09-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANDEL HEALTHCARE SAFETY DEVICES |
| Generic Name | WEIGHTED SAFETY SCALPEL |
| Product Code | GDX |
| Date Received | 2014-09-15 |
| Model Number | 2215-N |
| Lot Number | 1394 |
| Device Expiration Date | 2017-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL SANDEL MEDICAL SOLUTIONS LLC |
| Manufacturer Address | CHATSWORTH 91311 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-15 |