MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM 5955600 manufactured by Davol Inc..
[100661125]
Patient Sequence No: 1, Text Type: N, H10
[100661126]
Device was supposed to inflate the mesh against the abdominal wall to be secured. The balloon failed to inflate so surgical team then had to manually place mesh against the abdominal wall to be tacked into place. Rep was notified. Surgeon manually placed mesh against the abdominal wall to be tacked into place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7288418 |
| MDR Report Key | 7288418 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-02-09 |
| Report Date | 2018-02-14 |
| Date Reported to FDA | 2018-02-14 |
| Date Reported to Mfgr | 2018-02-14 |
| Date Added to Maude | 2018-02-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM |
| Generic Name | MESH, SURGICAL, DEPLOYMENT BALLOON |
| Product Code | OQL |
| Date Received | 2018-02-22 |
| Model Number | 5955600 |
| Catalog Number | 5955600 |
| Lot Number | HUBY0019 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC. |
| Manufacturer Address | 160 NEW BOSTON ST. WOBURN MA 01801 US 01801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-22 |