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 GALAFLEX? SCAFFOLD 100035-15 GP0408 manufactured by Tepha, Inc.
[139615032]
Review of manufacturing records indicated the product was produced to and met specifications. The sterilization cycle was reviewed and all parameters met specifications. Physician confirmed product packaging was undamaged and intact. The surgeon felt that the mrsa was community-acquired (or potentially due to patient colonization) and not hospital acquired. He believes that the bacteria colonized the mesh/implant site through the drains site once she left the hospital, as this provided a direct conduit for bacteria. The infection has resolved.
Patient Sequence No: 1, Text Type: N, H10
[139615033]
The surgeon reported that patient developed left breast infection 10 days post-op with mrsa. Temperature at 102f, requiring urgent removal of breast implant and mesh. Surgery to remove left breast implant and mesh occurred on (b)(6) 2019. The patient then developed symptoms in the right breast. Additional surgery to remove right breast implant and mesh occurred on (b)(6) 2019. Infection was determined to be likely community-acquired at the drains that were implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2019-00005 |
| MDR Report Key | 8445505 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-10 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2018-06-18 |
| 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 | GALAFLEX? SCAFFOLD |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2019-03-22 |
| Model Number | 100035-15 |
| Catalog Number | GP0408 |
| Lot Number | 170202 |
| 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 |