MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for MEDLINE MDS15310 manufactured by Medline.
[92318412]
While performing lipoma re-excision, the dr was making a stabbing motion incision to place a penrose drain when the scalpel blade broke off in the pt's back. The blade was located on x-ray; however, the dr was unable to retrieve the blade after two attempts. The wound was closed with the scalpel blade remaining in the pt and the pt has been referred to a local surgeon to have the blade removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073376 |
| MDR Report Key | 7037473 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-13 |
| Date of Event | 2017-10-19 |
| Date Added to Maude | 2017-11-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDLINE |
| Generic Name | DISPOSABLE SAFTY SCALPEL |
| Product Code | GDX |
| Date Received | 2017-11-15 |
| Catalog Number | MDS15310 |
| Lot Number | U00081 |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-15 |