MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-10 for MAYFIELD DISPOSABLE SKULL PINS A1072 manufactured by Integra Lifesciences Corporation.
[5872410]
Laceration to scalp found after placement of mayfield tongs requiring staples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4840218 |
| MDR Report Key | 4840218 |
| Date Received | 2015-06-10 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-04-03 |
| Date Facility Aware | 2015-04-03 |
| Report Date | 2015-05-01 |
| Date Reported to FDA | 2015-05-01 |
| Date Reported to Mfgr | 2015-05-01 |
| Date Added to Maude | 2015-06-15 |
| 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 | 3 |
| 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 | MAYFIELD DISPOSABLE SKULL PINS |
| Generic Name | DISPOSABLE SKULL PINS |
| Product Code | HAX |
| Date Received | 2015-06-10 |
| Model Number | A1072 |
| Lot Number | 1150092 |
| Device Expiration Date | 2017-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-10 |