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 2018-03-13 for MINI-SIZE LID W/RETENTION PLATESILVER JK174 manufactured by Aesculap Ag.
[102339974]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[102339975]
Country of complaint: (b)(6). It is reported that the seals are faulty. Components in use listed as concomitant devices are: jk174 / mini-size lid w/retention platesilver. Jk188 / bottom f/mini container height: 57 mm.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9610612-2018-00113 |
MDR Report Key | 7334583 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2018-03-13 |
Date of Report | 2018-03-13 |
Date Facility Aware | 2018-03-12 |
Date Mfgr Received | 2016-07-06 |
Date Added to Maude | 2018-03-13 |
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 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 | MINI-SIZE LID W/RETENTION PLATESILVER |
Generic Name | MINI CONTAINER BOTTOMS AND LIDS |
Product Code | FRG |
Date Received | 2018-03-13 |
Returned To Mfg | 2016-07-25 |
Model Number | JK174 |
Catalog Number | JK174 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | R |
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 | 2018-03-13 |