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 2017-06-06 for TUNNELING INSTRUMENT 600MM FV004R manufactured by Aesculap Ag.
[76744695]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[76744696]
Country of complaint: (b)(6). It was reported that the white tip of the device broke off and was under the skin of the patient. The tip was removed with no injury to the patient. There was also no surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2017-00314 |
| MDR Report Key | 6614445 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-06 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-05-09 |
| Date Facility Aware | 2017-05-17 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-06-06 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| 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 | TUNNELING INSTRUMENT 600MM |
| Generic Name | NSTRUMENTS FOR HYDROCEPHALUS VALVE |
| Product Code | HAO |
| Date Received | 2017-06-06 |
| Returned To Mfg | 2017-05-23 |
| Model Number | FV004R |
| Catalog Number | FV004R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2017-06-06 |