MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2020-01-09 for PHASIX FLAT MESH 1190400 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[188794406]
Root cause is undetermined. Based on the information provided, no conclusion can be made as to the cause of the hernia recurrence. As reported this patient has undergone multiply abdominal surgeries, including the index procedure, which included a panniculectomy, lysis of adhesions, abdominoplasty and removal of xiphoid exostosis. The clinician has indicted two possible reasons for the hernia recurrence; a possible mesh tear and a possibly weakened area due to the removal of xiphoid bone during index procedure. As reported the phasix mesh had resorbed (as intended) prior to the revision procedure as such there is no way to review for a possible tear. No conclusions can be made however, given the patient's medical/surgical history it is possible that the patient's comorbidities may have contributed to the hernia recurrence. Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be provided, a supplemental emdr will be submitted. No sample to return.
Patient Sequence No: 1, Text Type: N, H10
[188794407]
As reported per (b)(6) clinical study (b)(6): on (b)(6) 2014 the subject patient underwent repair of a primary midline incisional hernia using bard phasix mesh. An onlay placement without component separation technique was utilized. The length of the defect measured 30cm and the width measured 10cm. In addition to the hernia repair, a panniculectomy, lysis of adhesions, abdominoplasty and removal of xiphoid exostosis was performed. Perimeter fixation was performed with absorbable monofilament suture, 13 points of fixation were made. The wound and fascia were closed. Skin is recorded as fully closed. On (b)(6) 2015 the subject patient was diagnosed with a recurrent midline hernia. On (b)(6) 2015 the subject patient underwent additional surgery to repair the recurrent hernia. As reported, possible contributors to the recurrence are as documented: "possible mesh tear not able to confirm due to mesh is completely dissolved. " and " xiphoid bone removed during primary surgery, possibly weakened area. " the hernia recurrence was reported to have been located in the middle of the mesh. The recurrent hernia has been assessed per clinician as possibly related to the study device and definitely related to the index procedure. Per crf this ae has been assessed as a serious adverse event of moderate severity. The clinician "possible relates this to device failure but can not definitely relate due to mesh is fully dissolved. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00193 |
| MDR Report Key | 9570383 |
| Report Source | OTHER,STUDY |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2015-12-05 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2020-01-09 |
| 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 FLAT MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2020-01-09 |
| Model Number | NA |
| Catalog Number | 1190400 |
| Lot Number | HUYBTP04 |
| Device Expiration Date | 2016-04-28 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-09 |