MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-28 for HESSBURG BARRON * 21-8280 manufactured by Barron Precision Instruments.
[22041446]
As the staff tried to engage the device it would not produce any suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2935925 |
| MDR Report Key | 2935925 |
| Date Received | 2013-01-28 |
| Date of Report | 2013-01-28 |
| Date of Event | 2012-10-24 |
| Report Date | 2013-01-28 |
| Date Reported to FDA | 2013-01-28 |
| Date Added to Maude | 2013-01-30 |
| 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 |
| 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 | HESSBURG BARRON |
| Generic Name | TREPHINE, MANUAL, OPHTHALMIC, VACUUM |
| Product Code | HRH |
| Date Received | 2013-01-28 |
| Model Number | * |
| Catalog Number | 21-8280 |
| Lot Number | 11098731 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARRON PRECISION INSTRUMENTS |
| Manufacturer Address | 8170 EMBURY RD. GRAND BLANC MI 48439 US 48439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-28 |