MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-13 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[179250595]
At this time no conclusions can be made. The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol phasix mesh (device #3). Additional emdrs were submitted to represent the bard/davol composix e/x (device #1) and composix kugel hernia patch (device #2). Should additional information be provided a supplemental emdr will be submitted. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[179250596]
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x on (b)(6) 2004, composix kugel hernia patch on (b)(6) 2006 and phasix mesh on (b)(6) 2016. As reported, the patient is making a claim for an adverse patient outcome against all devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged that the patient experienced emotional distress and the device was defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-01192 |
| MDR Report Key | 9706037 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-13 |
| 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 | ANDREW TOPOULOS |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258495 |
| 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 | 2020-02-13 |
| 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. Required No Informationntervention | 2020-02-13 |