MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-18 for N-SPOTS 732 manufactured by Beekley Corporation.
[18986424]
Customer mis-applied the nipple marker to a patient's mammogram causing the skin to pull taught and the radiologist to request another mammogram image with the marker reapplied correctly.
Patient Sequence No: 1, Text Type: D, B5
[19064527]
Customer is evaluating other skin marker options to determine what will work better. They were also instructed on the best application method to eliminate this possibility with the use of the current product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9021987-2012-00019 |
| MDR Report Key | 2800977 |
| Report Source | 05 |
| Date Received | 2012-10-18 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-08-22 |
| Device Manufacturer Date | 2012-08-02 |
| Date Added to Maude | 2012-10-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | ONE PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N-SPOTS |
| Generic Name | SYSTEM, X-RAY, FILM MARKING, RADIOGRAPHI |
| Product Code | JAC |
| Date Received | 2012-10-18 |
| Model Number | 732 |
| Catalog Number | 732 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY CORPORATION |
| Manufacturer Address | BRISTOL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-18 |