MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-10 for SCALPEL #10 BLADE NSN 6515-00-233-5754 H&HECTK01 manufactured by H & H Medical Corporation.
[18570053]
The emergency medical transportation crew responded to a motor vehicle accident scene and a patient with multisystem trauma. After a failed attempt to intubate the patient due to swelling trauma etc. , an emergency cricothyrotomy kit was opened and the #10 scalpel blade was used to make an incision. The blade fell off and was retained in the patient's airway. The crew was able to ventilate the patient and so the failure of the scalpel did not compromise this otherwise critical patient. The scalpel blade is not available for manufacture's inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3428845 |
| MDR Report Key | 3428845 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-09-08 |
| Report Date | 2013-10-10 |
| Date Reported to FDA | 2013-10-10 |
| Date Reported to Mfgr | 2013-10-25 |
| Date Added to Maude | 2013-10-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALPEL #10 BLADE |
| Generic Name | NEEDLE, EMERGENCY AIRWAY |
| Product Code | BWC |
| Date Received | 2013-10-10 |
| Model Number | NSN 6515-00-233-5754 |
| Catalog Number | H&HECTK01 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | H & H MEDICAL CORPORATION |
| Manufacturer Address | 4173 G.W. MEMORIAL HIGHWAY ORDINARY VA 23131 US 23131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-10 |