MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2020-01-14 for PHASIX FLAT MESH 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[188795298]
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 multiple abdominal surgeries, including open end colostomy and colostomy reposition. The index procedure included a retro-rectus with component separation approach with rives-stoppa technique. A swiss cheese configuration (multiple discreet hernias) was noted. 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 obstruction and hernia recurrence. Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the ifu as a known 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
[188795299]
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence and obstruction. On (b)(6) 2015 the subject patient underwent repair of a primary midline incisional hernia utilizing the phasix mesh. A retro-rectus without component separation approach with rives-stoppa technique was used. The length of the swiss cheese defect measured 14 cm x 10 cm. Perimeter fixation was performed with absorbable monofilament suture. Eleven (11) points of fixation were made. The fascia was re-approximated and the skin was fully closed. On (b)(6) 2019 the patient was diagnosed with a small bowel obstruction and parastomal hernia recurrence. The patient was treated with a nasogastric tube and the obstruction resolved on (b)(6) 2019. On (b)(6) 2019 the patient underwent laparoscopic parastomal hernia repair. The hernia measured 4 cm by 4cm. There was no noted swiss cheese configuration. The phasix mesh was not explanted at this time and the fascia was re-approximated and the skin fully closed. The adverse events were assessed per the clinician as possible related to the study device and definitely related to the index procedure. The bowel obstruction and recurrence have been assessed per the study clinician as serious adverse events and of moderate and mild severity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00317 |
| MDR Report Key | 9588478 |
| Report Source | OTHER,STUDY |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2020-01-14 |
| 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 | STEVEN FIGUEROA |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258460 |
| 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 | 2020-01-14 |
| Model Number | NA |
| Catalog Number | 1190500 |
| Lot Number | HUYBTP05 |
| 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 | 2020-01-14 |