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 2018-09-12 for GALAFORM 3D 100043-02 FR3D02 manufactured by Tepha, Inc.
[120019367]
The physician reported that he did not feel that the device led to the infection, and that it was the incision itself that caused the infection. However, because the device may have contributed to the infection, the manufacturer is reporting out of an abundance of caution. As the manufacturer was not made aware in a timely manner, no analysis or testing can be done. Current device labeling addresses the reported event as follows: "possible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. "
Patient Sequence No: 1, Text Type: N, H10
[120019368]
Physician reported that in up to three breast surgeries (one mastopexy and two breast reductions) performed in the preceding months and in which he used galaform 3d, he observed redness/rash with infection. The issue was seen as wound dehiscence at the t-junction of the wound closure and followed the line of the product rim. Debridement was performed with a portion of the mesh removed, and the events resolved without sequelae. Physician reported that in up to three breast surgeries (one mastopexy and two breast reductions) performed in the preceding months and in which he used galaform 3d, he observed redness/rash with infection. The issue was seen as wound dehiscence at the t-junction of the wound closure and followed the line of the product rim. Debridement was performed with a portion of the mesh removed, and the events resolved without sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2018-00002 |
| MDR Report Key | 7870614 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-12 |
| Date of Report | 2018-08-30 |
| Date Mfgr Received | 2018-04-28 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2018-09-12 |
| 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 | GALAFORM 3D |
| Generic Name | SURGICAL SCAFFOLD |
| Product Code | OXF |
| Date Received | 2018-09-12 |
| Model Number | 100043-02 |
| Catalog Number | FR3D02 |
| Lot Number | 170166 |
| Device Expiration Date | 2018-04-28 |
| 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 SUITE 360 LEXINGTON MA 02421 US 02421 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-12 |