MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-30 for VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM 5955680 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[115376620]
Mesh device broke off in abdomen instead of coming out in one piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7731045 |
| MDR Report Key | 7731045 |
| Date Received | 2018-07-30 |
| Date of Report | 2018-06-30 |
| Date of Event | 2018-06-21 |
| Report Date | 2018-06-30 |
| Date Reported to FDA | 2018-06-30 |
| Date Reported to Mfgr | 2018-07-30 |
| Date Added to Maude | 2018-07-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 POSITIONING SYSTEM |
| Generic Name | MESH, SURGICAL, DEPLOYMENT BALLOON |
| Product Code | OQL |
| Date Received | 2018-07-30 |
| Model Number | 5955680 |
| Catalog Number | 5955680 |
| Lot Number | HUBT1674 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-30 |