MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-05-21 for PHASIX UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[145682702]
At this time no conclusions can be made regarding the bard/davol phasix (device #4) used to treat the patient. The patient's attorney did allege surgical intervention; however, no details have been provided. No lot number has been provided therefore a review of the manufacturing records is not possible. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol phasix (device #4). An additional emdr was submitted to represent the bard/davol bard flat mesh (device #1), bard/davol bard flat mesh (device #2) and bard/davol ventralight st (device #3). Not returned.
Patient Sequence No: 1, Text Type: N, H10
[145682703]
Attorney alleges that on (b)(6) 2015, (b)(6) 2017, or (b)(6) 2018, the patient underwent surgery for implant of unspecified bard/davol products: bard mesh (device #1) and (device #2), ventralight st (device #3), or phasix (device #4). It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device. As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (device #1) and (device #2), ventralight st (device #3), and phasix (device #4). As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-04150 |
| MDR Report Key | 8629163 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-21 |
| 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 | ROXANNE TIDWELL |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 8015652300 |
| Manufacturer G1 | TEPHA, INC |
| Manufacturer Street | 99 HAYDEN AVENUE EAST WING, SUITE 360 |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02421 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHASIX |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2019-05-21 |
| 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 | 2019-05-21 |