MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-08-29 for CT SPOTS LINE I-118 118 manufactured by Beekley Corporation.
[2757719]
Product did not have labeling affixed to the box.
Patient Sequence No: 1, Text Type: D, B5
[10013929]
Distributor was sent labels to affix to the packaging before re-sale.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9021987-2012-00013 |
| MDR Report Key | 2726430 |
| Report Source | 08 |
| Date Received | 2012-08-29 |
| Date of Report | 2012-08-15 |
| Date of Event | 2012-07-16 |
| Device Manufacturer Date | 2012-07-11 |
| Date Added to Maude | 2012-12-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHELSEA FITHIAN |
| Manufacturer Street | ONE PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT SPOTS LINE |
| Generic Name | SKIN MARKERS |
| Product Code | JAC |
| Date Received | 2012-08-29 |
| Model Number | I-118 |
| Catalog Number | 118 |
| Lot Number | I-118.07111201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY CORPORATION |
| Manufacturer Address | BRISTOL CT 06010 US 06010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-29 |