MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-06-11 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[110602516]
Currently, it is unknown to what extent the bard/davol phasix mesh device may have caused or contributed to the events as alleged by the patient? S attorney. The information provided alleges the patient underwent additional "repair surgery of the hernia and the hernia mesh" with removal of part of the mesh. A sample was not provided for evaluation and no lot number has been provided; therefore a review of the manufacturing records is not possible at this time. No medical records, autopsy, or death certificate have been provided. Based on the limited information provided at this time, no conclusions can be made. The actual date of explant is unknown, as reported by the decedent's attorney "underwent surgery in 2015... Removed part of the mesh", therefore we are using (b)(6) 2015 as a date of explant as well as date of event. Should additional information be provided a supplemental emdr will be submitted. Note: section a through f - the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[110602517]
The following was alleged by the patient's attorney: on (b)(6) 2013: the patient was implanted with a bard/davol phasix mesh for the repair of an incisional hernia. On (b)(6) 2015: the patient started experiencing pain radiating from his abdomen and neuropathy. Thereafter, the patients physicians elected for a repair surgery of the hernia and hernia mesh. Upon entering the abdominal cavity, the patients surgeon noted that the bard/davol phasix mesh had failed and removed part of the mesh. It is alleged that subsequent to the bard/davol phasix mesh implant surgery, the patient suffered substantial pain and suffering and has not been able to received proper care for his esophagus cancer because physicians were unable to place a feeding tube due to the mesh, and subsequently died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01885 |
| MDR Report Key | 7586470 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-11 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2018-06-04 |
| Date Added to Maude | 2018-06-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRANCESCA SANTAMARIA |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258538 |
| 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 | PHASIX MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2018-06-11 |
| Model Number | NA |
| Catalog Number | UNKAA091 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention; 3. Deathisabilit | 2018-06-11 |