MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for MEDIUM PENDANT 1200-900 MODUTEC ARD517025999 manufactured by Maquet Sas.
[77829292]
Additional information will be provided after investigation result.
Patient Sequence No: 1, Text Type: N, H10
[77829293]
On (b)(6) maquet (b)(4) became aware of an incident with the medium pendant device. It was stated that the end cap of the device was loose and fell off. No information about the circumstances and possible patient involvement were provided. The issue is being investigated. Manufacturer reference number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2017-00042 |
| MDR Report Key | 6643082 |
| Date Received | 2017-06-15 |
| Date of Report | 2018-03-20 |
| Date of Event | 2017-05-21 |
| Date Added to Maude | 2017-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal | 45074 |
| Manufacturer Phone | 0332382587 |
| Manufacturer G1 | FREDERIC LELEU - MAQUET SAS |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 45074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDIUM PENDANT 1200-900 MODUTEC |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2017-06-15 |
| Catalog Number | ARD517025999 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | ORL?ANS CEDEX 2 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |