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 2019-03-22 for GALATEA (SPECIFIC PRODUCT INFORMATION NOT PROVIDED) manufactured by Tepha, Inc.
[139616161]
Based on the information provided we are unable to determine to what extent, if any, the galatea device may have caused or contributed to the event. Tepha was informed that the reporter / complainant was unable or unwilling to provide any further information on the patient, product or procedural details. At this time, no conclusions can be made. No part number of lot number has been provided; therefore a review of manufacturing records could not be performed. The ifu includes information on possible complications and adverse reactions. If additional information is obtained, an emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139616162]
Physician reported on (b)(6) 2019 that a patient experienced spitting (extrusion) of the galaform mesh and had an infection. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2019-00004 |
| MDR Report Key | 8445511 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-15 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GALATEA (SPECIFIC PRODUCT INFORMATION NOT PROVIDED) |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2019-03-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-22 |