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 2018-11-15 for GALAFORM 3D 100043-04 FRSD04 manufactured by Tepha, Inc.
[127260073]
Based on the information provided by the physician, it appears that the pds suture most "lilkely" caused / contributed to the adverse event based on the terminology used "suture spit" (a spitting suture generally refers to a suture breaking through the surface of the skin. As sutures dissolve under the surface of the skin, some people's bodies can push parts of these sutures out of the body). The blister that formed was directly located at the surgical site. A review of device history records from the lots manufactured prior to the surgery was performed and concluded that the device was manufactured to specifications. Based on known information, there is no conclusive evidence that the device caused the adverse event. However it is not clear if the device (scaffold) contributed to the infection. This "adeverse" event is being reported in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[127260074]
Physician performed a mastopexy with wise pattern, central mound and galaform scaffold. Physician reported that initially there were no complications from the surgery. Patient was at about 8 months post surgery developed a blister in the intra-mammary fold at the inverted t area. Although the mesh is not exposed , it is directly below this thin area. At approximately 9 months out from surgery had pds sutures spit at inferior areolar border. The physician debrided a small area in the office. The physician observed some purulent material. He was able to close the site without too much trouble.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2018-00004 |
| MDR Report Key | 8074127 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-11 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2018-11-15 |
| 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 | 2018-11-15 |
| Model Number | 100043-04 |
| Catalog Number | FRSD04 |
| Lot Number | NOT KNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 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 | 2018-11-15 |