MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-08 for GALASHAPE? 3D SCAFFOLD 100042-04 SH3D04 manufactured by Tepha, Inc.
| Report Number | 3005670760-2019-00001 |
| MDR Report Key | 8769288 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-08 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2019-07-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS BARBARA RINALDI |
| Manufacturer Street | 99 HAYDEN AVE. SUITE 360 |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal | 02421 |
| Manufacturer Phone | 7813251758 |
| Manufacturer G1 | TEPHA, INC |
| Manufacturer Street | 99 HAYDEN AVE |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02421 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GALASHAPE? 3D SCAFFOLD |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2019-07-08 |
| Model Number | 100042-04 |
| Catalog Number | SH3D04 |
| Lot Number | 170582 |
| Device Expiration Date | 2018-12-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEPHA, INC |
| Manufacturer Address | 99 HAYDEN AVE LEXINGTON MA 02421 US 02421 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-08 |