MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for ZERO-GRAVITY ZGCM-66 manufactured by Tidi Products, Llc.
[54278922]
Patient Sequence No: 1, Text Type: N, H10
[54278923]
This incident was not made known to us until ~ two weeks ago. No patient involved. Incident involved a doctor using a zero-gravity overhead suspended radiation shielding system. The mechanical suspension means of the radiation shielding element ceased to hold up that component (root cause to be determined), resulting in it falling. The flexible shoulder shields glanced off the doctor's arms as it fell. The doctor reports that he was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825560-2016-00002 |
| MDR Report Key | 5912773 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-08-11 |
| Device Manufacturer Date | 2013-07-17 |
| Date Added to Maude | 2016-08-29 |
| 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. JOHN SCHAEFER |
| Manufacturer Street | 14241 FENTON ROAD |
| Manufacturer City | FENTON MI 48430 |
| Manufacturer Country | US |
| Manufacturer Postal | 48430 |
| Manufacturer Phone | 8105933232 |
| Manufacturer G1 | TIDI PRODUCTS, LLC |
| Manufacturer Street | 14241 FENTON ROAD |
| Manufacturer City | FENTON MI 48430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZERO-GRAVITY |
| Generic Name | RADIATION PROTECTION SYSTEM |
| Product Code | EAJ |
| Date Received | 2016-08-29 |
| Returned To Mfg | 2016-08-26 |
| Model Number | ZGCM-66 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 14241 FENTON ROAD FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |