MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-10-25 for VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH 4000001-11 manufactured by Sentinelle Medical, Inc..
[21968711]
This adverse event was reported by the ge clinical product surveillance specialist ((b)(4)) as such: "on thursday the lead tech pulled the sentinelle mammo table's lower accessory drawer out and it fell on her foot. Her foot was injured but did not require medical treatment. " ge healthcare has contacted the site 3 add'l times to obtain more info on the extent of the foot injury and to see if pt follow-up is required. Site has not responded.
Patient Sequence No: 1, Text Type: D, B5
[22361871]
A ge healthcare field engineer (fe) was dispatched to affected site. The fe reported that the left drawer slide had pulled over its mechanical stop and the right drawer slide was bent and had completely broken apart. Both slide assemblies to be replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005748597-2013-00003 |
| MDR Report Key | 3452895 |
| Report Source | 00 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-11 |
| Date Mfgr Received | 2013-10-18 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2013-12-09 |
| 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 | JOAN MEDLEY, DIRECTOR |
| Manufacturer Street | 555 RICHMOND STREET SUITE 800 |
| Manufacturer City | TORONTO, ONTARIO M5V 3B1 |
| Manufacturer Country | CA |
| Manufacturer Postal | M5V 3B1 |
| Manufacturer Phone | 6472583607 |
| Manufacturer G1 | SENTINELLE MEDICAL, INC. |
| Manufacturer Street | 3080 YONGE STREET SUITE 6020 |
| Manufacturer City | TORONTO, ONTARIO |
| Manufacturer Country | CA |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH |
| Generic Name | COIL, MAGNETIC RESONANCE, SPECIALTY |
| Product Code | MOS |
| Date Received | 2013-10-25 |
| Model Number | 4000001-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENTINELLE MEDICAL, INC. |
| Manufacturer Address | 555 RICHMOND STREET WEST STE 800 TORONTO, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-25 |