MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,study report with the FDA on 2018-08-28 for PHASIX MESH 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[118424775]
Based on the information provided at this time, no conclusion can be made as to the degree to which the mesh implant used to treat the patient may have caused or contributed to the recurrent hernia. As reported, the patient has a complicated medical/surgical history and has undergone multiple surgeries including previous hernia repair. Additionally, the index procedure was complicated by events unrelated to the study device. The adverse event of recurrence is assessed by the clinician as mild in severity, possibly related to the study device, and possibly related to the procedure. Based on the information provided, no definitive conclusion can be made at this time. Recurrence is a known inherent risk of hernia repair surgery. The adverse reaction section of the instructions-for-use identifies recurrence as a possible complication, additionally the warning section states, "to prevent recurrences when repairing hernias, the phasix mesh must be large enough to provide sufficient overlap beyond the margins of the defect. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[118424776]
It was reported that a patient who is part of a clinical study ((b)(6)) experienced a hernia recurrence on (b)(6) 2016 - the subject patient underwent left inguinal hernia repair with phasix mesh utilizing onlay placement with component separation, posterior technique, a panniculectomy and lysis of adhesions. Also performed at this time was an ileo-rectal anastomosis, and loop ileostomy. The fascia and skin of the wound were fully closed. A urinary bladder perforation occurred during this procedure, which was repaired, and a urinary catheter was placed. On (b)(6) 2016 - the subject patient experienced a severe pulmonary embolism. Per the information provided "patient was immobilized post op and he is relatively obese he had also just had a huge operation. These risk factors predispose him to a pe (pulmonary embolism). " the clinician reported the pe was unrelated to the device used to treat the hernia. On (b)(6) 2018 - the subject patient was diagnosed with a hernia recurrence. The hernia recurrence was detected at referring hospital while patient was being cared for there. This alleged recurrence will be verified during the patient's two year follow up. The recurrence is assessed by the clinician as mild in severity, possibly related to the study device, and possibly related to the procedure. At this time there is no reported medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02944 |
| MDR Report Key | 7822462 |
| Report Source | FOREIGN,OTHER,STUDY |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2018-08-28 |
| 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 | LAURA SUNDBERG |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258462 |
| 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 | 2018-08-28 |
| Model Number | NA |
| Catalog Number | 1190500 |
| Lot Number | HUAS0690 |
| Device Expiration Date | 2018-05-28 |
| 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 | 2018-08-28 |