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 2020-02-03 for ASEPTIC TRANSFER KIT HOUSING N/A 89-8510-440-10 manufactured by Zimmer Surgical Sa.
| Report Number | 0008031000-2020-00005 |
| MDR Report Key | 9658742 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2015-10-09 |
| Date Added to Maude | 2020-02-03 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL SA |
| Manufacturer Street | 3, CH. DU PRE FLEURI 1228 PLAN-LES-OUATES |
| Manufacturer City | GENEVA CH-1228 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-1228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASEPTIC TRANSFER KIT HOUSING |
| Generic Name | ASEPTIC TRANSFER KIT HOUSING |
| Product Code | MOQ |
| Date Received | 2020-02-03 |
| Model Number | N/A |
| Catalog Number | 89-8510-440-10 |
| Lot Number | 5007188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL SA |
| Manufacturer Address | CHEMIN DU PRE FLEURI, 3 PLAN-LES-OUATES GENEVA CH-1228 SZ CH-1228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-03 |