MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-14 for TABLE ADAPTA 3 I-SKIN PAC BLUE 3320101 manufactured by Djo, Llc.
[133086560]
.
Patient Sequence No: 1, Text Type: N, H10
[133086561]
It was reported that the weld on the table frame broke when a patient sat down on it. The patient was reportedly not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00003 |
| MDR Report Key | 8245035 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-14 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-01-14 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TABLE ADAPTA 3 I-SKIN PAC BLUE |
| Generic Name | TABLE, POWERED |
| Product Code | INQ |
| Date Received | 2019-01-14 |
| Model Number | 3320101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-14 |