MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-12 for DOUBLESPIR-AIR-HOSE L2M F/SYST-SYNTHES 519.550 manufactured by Depuy Synthes Products Llc.
[97751371]
Udi: gtin is unavailable as the product made prior to compliance date. (b)(6). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[97751372]
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the air hose device had an air leak. It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-50238 |
| MDR Report Key | 7187845 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-15 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2014-08-25 |
| Date Added to Maude | 2018-01-12 |
| 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. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | HAUPTSTRASSE 24 |
| Manufacturer City | WALDENBURG |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLESPIR-AIR-HOSE L2M F/SYST-SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2018-01-12 |
| Catalog Number | 519.550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |