MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-09-28 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[122007375]
At this time no conclusions can be made. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. There was no specific reason given for the medical consultations and no medical records have been provided. Information is limited at this time. "should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol phasix mesh (device #2). An additional emdr was submitted to represent the bard/davol ventrio st (device #1). 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
[122007376]
The following was alleged by the patient's attorney: (b)(6) 2016: the patient underwent surgery for implant of an unspecified bard/davol ventrio st (device #1) and an unspecified bard/davol phasix mesh (device #2). The patient had unspecified injuries, including consultations with medical providers. The patient is making a claim for an adverse patient outcome against the bard/davol ventrio st (device #1) and phasix (device #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 | 1213643-2018-03319 |
| MDR Report Key | 7918089 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-28 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2018-09-28 |
| 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 | PHASIX MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2018-09-28 |
| 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; 2. Deathisabilit | 2018-09-28 |