MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-20 for N-FREE SPOT DESIGNED FOR DIGITAL 732 manufactured by Beekley Medical.
[4153618]
Nipple marker product falling off patient during a mammogram, and in some cases, resulting in a repeat mammogram.
Patient Sequence No: 1, Text Type: D, B5
[11710706]
Nipple marker product has adhesive properties that may become compromised during use dependent on handling and application.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9021987-2014-00001 |
| MDR Report Key | 3610848 |
| Report Source | 05,06 |
| Date Received | 2014-01-20 |
| Date of Report | 2014-01-20 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-09 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-02-07 |
| 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 Contact | KATE CHASE |
| Manufacturer Street | 1 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-FREE SPOT DESIGNED FOR DIGITAL |
| Generic Name | NIPPLE MARKER |
| Product Code | JAC |
| Date Received | 2014-01-20 |
| Returned To Mfg | 2014-01-20 |
| Model Number | 732 |
| Catalog Number | 732 |
| Lot Number | 732.11271301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY MEDICAL |
| Manufacturer Address | BRISTOL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-20 |