MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for STERILE C SECTION PACK manufactured by Cardinal Health/medline.
[73408742]
During a c-section the tip of the pencil cautery, bovie, was placed on hemostat for coagulation and did not work properly. It was noted that the tip had ignited with a flame. This is the second pencil cautery that is packaged in a c-section pack by (b)(4) that has ignited unexpectedly and without patient harm. The pencil cautery is manufactured by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069245 |
| MDR Report Key | 6512477 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-04-18 |
| Date Added to Maude | 2017-04-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 SECTION PACK |
| Generic Name | CESAREAN SECTION TRAY |
| Product Code | OHM |
| Date Received | 2017-04-20 |
| Lot Number | 655334 |
| Device Expiration Date | 2017-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH/MEDLINE |
| Manufacturer Address | WAUKEGAN IL US |
| Brand Name | PENCIL CAUTERY |
| Generic Name | PENCIL CAUTERY |
| Product Code | GEI |
| Date Received | 2017-04-20 |
| Lot Number | 63340247X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-20 |