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 2019-05-07 for AIR HOSE 5.0M SCHRADER/AESCULAP SMALL GA506R manufactured by Aesculap Ag.
[144969843]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[144969844]
It was reported the outer tube burst intraoperatively. During a surgical procedure it was reported that the outer tube of the air hose burst. No staff or patient harm. No additional information has been provided. Associated medwatch: 9610612-2019-00306.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00305 |
| MDR Report Key | 8588529 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-07 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-04-05 |
| Date Facility Aware | 2019-06-26 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2014-10-20 |
| Date Added to Maude | 2019-05-07 |
| 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 Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR HOSE 5.0M SCHRADER/AESCULAP SMALL |
| Generic Name | HIGHSPEED POWER SYSTEMS |
| Product Code | GET |
| Date Received | 2019-05-07 |
| Returned To Mfg | 2019-05-02 |
| Model Number | GA506R |
| Catalog Number | GA506R |
| Lot Number | 52079373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 53 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-07 |