N
Patient 1
AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.
MAUDE MDR 7067132
- MDR report key
- 7067132
- Report number
- 8030965-2017-50146
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-10-20
- Date received
- 2017-11-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. MICHAEL COTE
- Address
- 1302 WRIGHTS LANE EAST WEST CHESTER PA
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DOUBLEAIRHOSE L3M F/SYST-SYNTHES | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT | DEPUY SYNTHES PRODUCTS LLC | HSZ | NA | 519.510 | NA | * | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-11-29 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DOUBLE AIR HOSE DEVICE WAS LEAKING AIR. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED. 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.