MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2020-01-10 for PHASIX FLAT MESH 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[185898208]
Based on the information provided, no conclusion can be made as to the cause of the hernia recurrence. The patient had previously undergone a hemicolectomy. During the hernia repair surgery the previous procedure (hemicolectomy) was completed with a takedown of ileostomy with ileocolonic anastomosis. The cause of the patient's hernia recurrence is unknown at this time. To date there has been no surgical intervention. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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
[185898209]
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence. As reported per phasix clinical study dvl-he-011: on (b)(6) 2014 the subject patient underwent repair of a primary ventral hernia utilizing bard phasix mesh. An onlay placement with component separation, ramirez/open technique was performed. The length of the defect measured 24cm and measured 15cm in width. In addition to this procedure, lysis of adhesions and a takedown of ileostomy with ileocolonic anastomosis was performed. The method of perimeter fixation was absorbable monofilament suture with 20 fixation points. The fascia was re-approximated and the skin was fully closed. On (b)(6) 2017 the subject patient was diagnosed with a recurrent hernia. The adverse event has been assessed per the clinician as possibly related to the study device and possibly related to the index procedure. The adverse event has been assessed as mild in severity, not serious with an ongoing resolution date. No action has been taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00244 |
| MDR Report Key | 9574819 |
| Report Source | OTHER,STUDY |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2013-08-20 |
| Date Added to Maude | 2020-01-10 |
| 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 | 2020-01-10 |
| Model Number | NA |
| Catalog Number | 1190500 |
| Lot Number | HUXCTP09 |
| Device Expiration Date | 2014-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-10 |