MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for VS200 WALL STAND 110-5010G1 manufactured by Del Medical Inc..
[146653504]
During a recent fda inspection it was observed tht we did not submit a medical device report for additional instances that were already reported. This report is to correct that observation.
Patient Sequence No: 1, Text Type: N, H10
[146653505]
The wall cassette receptor fell to the floor and was no longer attached to the counterweight cable. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418964-2019-00014 |
| MDR Report Key | 8511409 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2014-10-28 |
| Date Mfgr Received | 2014-10-28 |
| Device Manufacturer Date | 2011-01-14 |
| Date Added to Maude | 2019-04-12 |
| 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 | MR. WILLIAM KOSTECKI |
| Manufacturer Street | 241 COVINGTON DRIVE |
| Manufacturer City | BLOOMINGDALE IL 60108 |
| Manufacturer Country | US |
| Manufacturer Postal | 60108 |
| Manufacturer Phone | 8472887022 |
| Manufacturer G1 | DEL MEDICAL INC. |
| Manufacturer Street | 241 COVINGTON DRIVE |
| Manufacturer City | BLOOMINGDALE IL 60108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60108 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | 1418964-10/14/15-001-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VS200 WALL STAND |
| Generic Name | RADIOGRAPHIC CASSETTE HOLDER |
| Product Code | IXY |
| Date Received | 2019-04-12 |
| Model Number | VS200 |
| Catalog Number | 110-5010G1 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEL MEDICAL INC. |
| Manufacturer Address | 241 COVINGTON DRIVE BLOOMINGDALE IL 60108 US 60108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |