MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-11-20 for GALAFLEX? SCAFFOLD 100035-15 GP0408 manufactured by Tepha, Inc.
[128045697]
This event occurred in (b)(6) and was reported to tepha through the (b)(4) distributor. The physician reported the issue to the regional sales manager of the distributor when she asked for feedback from the physician. The issue was observed when the doctor saw the patient months later after the surgery for follow-up. It was not reported to either the sales manager or to tepha at that time. The patient underwent radiopathy after the initial surgery and the allergan breast implant moved significantly. It is unknown if the sutures used to fixate the galaflex scaffold were adequate to hold the implant and the scaffold. It is inconclusive if the scaffold caused or contributed to the patient condition. This event is being reported in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[128045698]
Physician reported to sales rep approximately 1 year after a surgery he performed - nipple sparing mastectomy with immediate reconstruction, using anatomic allergan 195cc implant under the muscle. Galaflex used in lower pole to give additional support to imf and cover implant. Following surgery, the patient received radiotherapy. The implant moved significantly following this and patient will require further surgery to revise the location of the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2018-00005 |
| MDR Report Key | 8090950 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2016-07-23 |
| Date Added to Maude | 2018-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 SCAFFOLD, PRODUCT CODE: OXF |
| Product Code | OXF |
| Date Received | 2018-11-20 |
| Model Number | 100035-15 |
| Catalog Number | GP0408 |
| Lot Number | 160317 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-11-20 |