MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-08-08 for HALSTED-MOSQUITO FCPSDELSTR1X2125MM BH120R manufactured by Aesculap Ag & Co. Kg.
[4811387]
Country of complaint: (b)(6). Complaint states: after finishing the surgery, the customer found tip of the jaw is missing. And that fragment has not been found yet.
Patient Sequence No: 1, Text Type: D, B5
[12006403]
U. S. Reporting agent notified on (b)(4) 2014. Manufacturing site evaluation: the investigation determined the issue had been caused by a manufacturing error, which was not detected in final inspection. However, all responsible persons have been informed about it and it should be avoided in the future. All known complaints with this failure have been produced in 2012. As oem did not receive any more issues since then, it is assumed that one or few batches in 2012 were affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00647 |
| MDR Report Key | 4047730 |
| Report Source | 01,07 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-08-07 |
| Date of Event | 2014-06-30 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2012-08-27 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P.O. 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 | HALSTED-MOSQUITO FCPSDELSTR1X2125MM |
| Generic Name | HAEMOSTATIC FORCEPS |
| Product Code | HRQ |
| Date Received | 2014-08-08 |
| Model Number | BH120R |
| Catalog Number | BH120R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-08 |