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 GALAFORM? SCAFFOLD 3D 100043-06 FR3D06 manufactured by Tepha, Inc.
[139616998]
A review of the manufacturing and sterilization records was performed and found that the lot was manufactured to and met all specifications and the sterilization cycle met validated parameters. No conclusion can be made. As reported, the reason for the mycobacterium infection could not be determined based on the information provided. M. Abscessus is a bacterium part of a group of environmental mycobacteria and is found in water, soil, and dust. It has been known to contaminate medications and products, including medical devices. M. Abscessus can cause a variety of infections. Healthcare-associated infections due to this bacterium are usually of the skin and the soft tissues under the skin. People with open wounds or who receive injections without appropriate skin disinfection may be at risk for infection by m. Abscessus. At this time, we are unable to determine to what degree, if any, the mesh implant used on the patient may have caused or contributed the patient's condition. Infection is a known inherent risk of surgery with or without the use of mesh. If additional information is provided, an emdr will be submitted. Tepha has made several attempts to obtain additional information, however the reporter / complainant was unable or unwilling to provide any further information on the patient, product or procedural details.
Patient Sequence No: 1, Text Type: N, H10
[139616999]
Doctor stated the patient developed a "mycobacterium abscessus" infection after the initial surgery and had to be on steroids and antibiotics for 6 months. He removed the mesh and the infection came back again. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005670760-2019-00003 |
| MDR Report Key | 8445508 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2017-11-14 |
| 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 | GALAFORM? SCAFFOLD 3D |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2019-03-22 |
| Model Number | 100043-06 |
| Catalog Number | FR3D06 |
| Lot Number | 170503 |
| Device Expiration Date | 2018-11-05 |
| 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 |