MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-11 for PRESTIGE RETR GRASPER DBL-ACT 5MM 8361-10 manufactured by Aesculap Inc.
| Report Number | 2916714-2019-00084 |
| MDR Report Key | 9181083 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-11 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-09-09 |
| Date Mfgr Received | 2019-11-01 |
| Date Added to Maude | 2019-10-11 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | MICRO STAMPING |
| Manufacturer Street | 100 BELMONT DRIVE |
| Manufacturer City | SOMERSET NJ 08873 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08873 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTIGE RETR GRASPER DBL-ACT 5MM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | NWV |
| Date Received | 2019-10-11 |
| Returned To Mfg | 2019-10-02 |
| Model Number | 8361-10 |
| Catalog Number | 8361-10 |
| Lot Number | M46651 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |