MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-08-21 for PHASIX 1190300 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[117827368]
Currently, it is unknown to what extent the bard/davol phasix device may have caused or contributed to the reported event. The attorney alleges the bard representative informed the physician post implant that the mesh used was not appropriate for the procedure and the patient underwent an additional surgery to remove the device. To date no medical records have been provided and based on the limited information at present, it is unclear how the mesh was specifically used and placed. The warning section of the ifu states? Phasix mesh must not be put in direct contact with bowel or viscera.? A review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided a supplemental emdr will be submitted. 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
[117827369]
The following was alleged by the patient's attorney per legal letter: on (b)(6) 2017: the patient had developed an incisional hernia that was gradually getting bigger. Plan was to do a laparoscopic repair. On (b)(6) 2017: the surgery performed was a laparoscopic ventral incisional hernia repair with mesh and lysis of adhesions. The mesh that was originally implanted was a bard/davol phasix. On (b)(6) 2017: the surgical note made by physician, "informed by bard rep yesterday that mesh used was not appropriate for intraabdominal use. " the patient was informed and the plan was to immediately remove and replace the mesh to avoid any further complications. The incorrect mesh used on (b)(6) 2017 did not have an adhesion barrier; thus, the patient was at risk for erosion into the bowel. The mesh implant that was used as a replacement was a non-bard/davol mesh. This mesh is designed for hernia repair. On (b)(6) 2017: the patient was discharged. The operative report states that they "opted to return her to surgery as soon as possible in order to minimize her recovery. " however, the patient's recovery time would not have been at issue had the appropriate mesh been implanted during the first surgery. This resulted in an additional surgery, more hospitalization, and additional pain and suffering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02850 |
| MDR Report Key | 7803233 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-08-21 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2018-08-21 |
| 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 | 8015652659 |
| 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 |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2018-08-21 |
| Model Number | NA |
| Catalog Number | 1190300 |
| Lot Number | HUAZ0047 |
| Device Expiration Date | 2018-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-21 |