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 2019-03-14 for GALAFLEX? SCAFFOLD 100035-09 GP0806 manufactured by Tepha, Inc.
[138836229]
The mesh was fixated with 2-0 vicryl, deep dermis and closed with 3-0 pds, 3-0 pds to reapproximate skin, 3-0 pds to close all deep dermis incisions, 3-0 prolene subcuticular to close inframammary and vertical limb incisions, 4-0 pdo quill subcuticular to inset the nipple areolar complex. Incisions covered with steristrips. Device history records were reviewed for the lot and product met all acceptance criteria. Due to the multiple medical devices and drugs used in the surgery, it is inconclusive whether the galaflex scaffold caused or contributed to the rash.
Patient Sequence No: 1, Text Type: N, H10
[138836230]
Physician reported on (b)(6) 2019 that a patient had an allergic reaction post surgery. The patient underwent surgery for the following procedures: bilateral breast liposuction, removal of bilateral saline implants, replacement of new silicone implants, mastopexy/reinforcement with galaflex mesh. The physician prepared the pocket with hypochlorous acid, followed with betadine. The new implants were allergan smooth silicone breast implant and galaflex mesh. Patient reported to physician that a systemic rash developed but the date of first rash occurrence is not currently known. Physician reported there was skin necrosis at t junction this was treated with topical antibiotic cream/ointment and resolved over time. Hyperbaric oxygen therapy was performed. Silvadene (silver sulfadiazine antibiotic). Prednisone (rash resolved). Current status: rash has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2019-00002 |
| MDR Report Key | 8422090 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2019-03-14 |
| 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 | 2019-03-14 |
| Model Number | 100035-09 |
| Catalog Number | GP0806 |
| Lot Number | 180150 |
| 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 | 2 | 1. Other | 2019-03-14 |