MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-03 for VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM 5955600 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[56186452]
Patient Sequence No: 1, Text Type: N, H10
[56186453]
Surgeon tacked mesh to abdominal wall with absorbable tacks, removing echo ps positioning system from tacked mesh by pulling in normal fashion. The echo ps positioning system was delivered through 12mm operative port with laparoscopic grasper. While doing, surgeon discovered that a piece (approximately 4. 5cm x 2cm) tore from the main body of the echo ps positioning framework landing on mesentery. Retrieval was done by surgeon immediately, with laparoscopic instrument. The torn piece was compared to the missing area on the main body of the positioning system(previously delivered) and determined by the surgeon that the entire torn piece was removed successfully causing no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5993255 |
| MDR Report Key | 5993255 |
| Date Received | 2016-10-03 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-08-24 |
| Report Date | 2016-09-20 |
| Date Reported to FDA | 2016-09-20 |
| Date Reported to Mfgr | 2016-09-20 |
| Date Added to Maude | 2016-10-03 |
| 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, POLYMERIC, DEPLOYMENT BALLOON |
| Product Code | OQL |
| Date Received | 2016-10-03 |
| Model Number | 5955600 |
| Catalog Number | 5955600 |
| Lot Number | HHUZK0663 |
| Device Expiration Date | 2017-11-28 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BOULEVARD WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-03 |