MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for O-SPOT 652 manufactured by Beekley Corporation.
[75176043]
A partial lot of o-spot (ref 652) product was found to be mis-labeled with a-spot (ref 651) labels.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9021987-2017-00001 |
| MDR Report Key | 6562862 |
| Date Received | 2017-05-12 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-05-03 |
| Date Mfgr Received | 2017-05-03 |
| Device Manufacturer Date | 2017-04-25 |
| Date Added to Maude | 2017-05-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATE CHASE |
| Manufacturer Street | 1 PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Manufacturer G1 | BEEKLEY CORPORATION |
| Manufacturer Street | 1 PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O-SPOT |
| Generic Name | MOLE MARKERS |
| Product Code | JAC |
| Date Received | 2017-05-12 |
| Returned To Mfg | 2017-05-10 |
| Model Number | 652 |
| Catalog Number | 652 |
| Lot Number | 652.04251701 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY CORPORATION |
| Manufacturer Address | 1 PRESTIGE LANE BRISTOL CT 06010 US 06010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-12 |