MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for STERILE C-SECTIN PACK CAUTERY manufactured by Cardinal Health/medline Industries.
[73063272]
Pencil cautery that was part of a c-section pack prepared by (b)(6), the tip of the bovie caught on fire and was removed from use before injury to patient. Pencil cautery is made by (b)(4), however, since it comes as part of the c-section pack there is no lot number for the cautery itself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069169 |
| MDR Report Key | 6500874 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-04-14 |
| Date Added to Maude | 2017-04-18 |
| 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 | ATTORNEY |
| 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 | 3 |
| Brand Name | STERILE C-SECTIN PACK CAUTERY |
| Generic Name | STERILE C-SECTIN PACK CAUTERY |
| Product Code | OKV |
| Date Received | 2017-04-17 |
| Lot Number | 655334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH/MEDLINE INDUSTRIES |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-17 |