MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-07-28 for HALSTED-MOSQUITO FCPSDELSTR1X2125MM BH120R manufactured by Aesculap Ag & Co. Kg.
[18369493]
Country of complaint: (b)(6). Complaint: the mouse tooth of the jaw was missing. When the surgeon tried to use this product in surgery, e found that the mouse tooth of the jaw was missing. The fragment has not been found yet. Primary surgery: (b)(6) 2014. Revision surgery: none. Pt data: unk. Further detail: none. Involved component: none. Reason for vigilance suspicious: fragment has not been found.
Patient Sequence No: 1, Text Type: D, B5
[18465012]
Us reporting agent notified on (b)(4) 2014. Mfg site evaluation: the issue has been caused by a mfg error, which was not detected in final inspection. All responsible personnel have been informed regarding this issue in order to ensure it is avoided in the future. No further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00583 |
| MDR Report Key | 4120804 |
| Report Source | 01,07 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-04-24 |
| Date Mfgr Received | 2014-04-24 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2014-10-06 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO KG |
| 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 | HALSTED-MOSQUITO FCPSDELSTR1X2125MM |
| Generic Name | VASCULAR CLAMP |
| Product Code | HRQ |
| Date Received | 2014-07-28 |
| Model Number | BH120R |
| Catalog Number | BH120R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-28 |