MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-05-15 for VENTRALEX ST UNKAA086 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[145161303]
At this time no conclusions can be made to what extent the bard/davol ventralex st(device #1) may have caused or contributed to the reported event. The cause of the patient postoperative complications cannot be determined at this time. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. Information is limited. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol ventralex st(device #1). An additional emdr was submitted to represent the bard/davol ventralex st (device #2). Not returned.
Patient Sequence No: 1, Text Type: N, H10
[145161304]
Attorney alleges that the patient underwent surgery during which the patient was implanted with an unspecified bard/davol ventralex st (device #1 and device #2) on (b)(6) 2012 and (b)(6) 2014. As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex st (devices #1 and #2). The attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-03955 |
| MDR Report Key | 8613342 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-15 |
| 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 | JAN LING |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 8015652663 |
| Manufacturer G1 | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRALEX ST |
| Generic Name | SURGICAL MESH |
| Product Code | FZH |
| Date Received | 2019-05-15 |
| Model Number | NA |
| Catalog Number | UNKAA086 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Deathisabilit | 2019-05-15 |