MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-25 for VENTROFIL SUTURE SET-STEELWIRE 1X90CM 2X 993034 manufactured by B.braun Surgical Sa.
[143848106]
(b)(4). Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. When additional information is received, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[143848107]
It was reported the patient has infection and tissue reaction. The reporter indicated that they are having problems with ventrofil stating the suture causes infection and a reaction in the tissues right away, 3-4 days after implantation. The reporter states they use an antiseptic substance to protect the polyethylene plate area, but have also found reactions in this area anyway. No other information has been provided. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2019-00388 |
| MDR Report Key | 8552715 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-25 |
| Date of Report | 2019-06-13 |
| Date Facility Aware | 2019-05-16 |
| Date Mfgr Received | 2019-05-16 |
| Date Added to Maude | 2019-04-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| Manufacturer G1 | B/ BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTROFIL SUTURE SET-STEELWIRE 1X90CM 2X |
| Generic Name | OTHER SUTURE |
| Product Code | KGS |
| Date Received | 2019-04-25 |
| Model Number | 993034 |
| Catalog Number | 993034 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-25 |