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 2018-10-24 for GALASHAPE 3D 100042-06 SH3D06 manufactured by Tepha, Inc.
[124839225]
Based on known information, there is no conclusive evidence that the device caused or contributed to the infection. Infection is a known inherent risk of surgery. Regarding infection- the warning section of the instructions for use states, "if an infection develops, treat the infection aggressively. An unresolved infection may require removal of the scaffold. "
Patient Sequence No: 1, Text Type: N, H10
[124839228]
Physician reported that 9 days after the surgery; re-augmentation of left breast with implant and mesh located at the inferior pole (left breast only), the patient presented an elevated white blood cell count and showed signs and symptoms of an infection - redness, fever, malaise and aches. The patient was sent to the hospital, the breast implant and mesh were removed, the area flushed and a new implant was placed. No mesh was used in the second surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2018-00003 |
| MDR Report Key | 8000102 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-08-30 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2018-10-24 |
| 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 | 7813571758 |
| Manufacturer G1 | TEPHA, INC |
| Manufacturer Street | 99 HAYDEN AVE SUITE 360 |
| 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 | GALASHAPE 3D |
| Generic Name | SURGICAL SCAFFOLD |
| Product Code | OXF |
| Date Received | 2018-10-24 |
| Model Number | 100042-06 |
| Catalog Number | SH3D06 |
| Lot Number | 170413 |
| Device Expiration Date | 2018-09-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEPHA, INC |
| Manufacturer Address | 99 HAYDEN AVE SUITE 360 LEXINGTON MA 02421 US 02421 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-24 |