MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-22 for BARD-PARKER SAFETY SCALPEL 372611 manufactured by Aspen Surgical Products, Inc..
[3171784]
Employee abdominal area was punctured when he was opening the package; the scalpel came out with the safety lock shield in the open position.
Patient Sequence No: 1, Text Type: D, B5
[10579365]
Due to a recent fda inspection this mdr is being reported late as a result of a re-evaluation. Actual device reviewed, review of the dhr was conducted. No failures found for the dhr review, but problem could be contributed to the hand loading of scalpels during packaging, handling and storage. Deficiency in either the handling/storage of the product, or the end user's technique in opening the package.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836161-2013-00055 |
| MDR Report Key | 2979925 |
| Report Source | 06 |
| Date Received | 2013-02-22 |
| Date of Report | 2013-02-22 |
| Date of Event | 2011-08-10 |
| Date Mfgr Received | 2011-08-10 |
| Date Added to Maude | 2013-02-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6945 SOUTHBELT DRIVE SE |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6166987100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD-PARKER SAFETY SCALPEL |
| Generic Name | SCALPEL, ONE-PIECE |
| Product Code | GDX |
| Date Received | 2013-02-22 |
| Catalog Number | 372611 |
| Lot Number | 0342292 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | CALEDONIA MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-22 |