MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-16 for MODUTEC ARD517001948 manufactured by Maquet Sas.
[183487602]
Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[183487603]
On (b)(6) 2017 getinge became aware about customer allegation related to end cap which fell off from the modutec device. There is no information about patient involvement, however we decided to report this case in abundance of caution as any parts falling down into sterile field might led to contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00040 |
| MDR Report Key | 9833820 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-03 |
| Date Added to Maude | 2020-03-16 |
| 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. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODUTEC |
| Generic Name | LIGHT, SURGICAL, CEILING MOUNTED |
| Product Code | FSY |
| Date Received | 2020-03-16 |
| Catalog Number | ARD517001948 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |