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 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[188794555]
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 a history of crohn's disease and had undergone multiply abdominal surgeries subsequently developing an 8cm x 18cm swiss cheese incisional hernia. 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. 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
[188794556]
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence. On (b)(6) 2015 the subject patient underwent an open repair of a first time recurrent midline incisional hernia using the phasix mesh. A retro-rectus placement with component separation ramirez technique was utilized. The length of the swiss cheese like defect measured 8 cm and the width measured 18 cm. Perimeter fixation was performed with absorbable monofilament suture. Eight (8) points of fixation were made. The wound and fascia were closed, the skin was fully closed. On (b)(6) 2017 the subject patient was diagnosed with a recurrent hernia (7 x 7 cm) in the same location. On (b)(6) 2017 the subject patient underwent additional surgery to repair the recurrent hernia. A primary repair was performed. This recurrent hernia has been assessed per the study clinician as possibly related to the device and definitely related to the index procedure. The clinician has assessed the recurrence as a serious adverse event of moderate severity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00194 |
| MDR Report Key | 9571993 |
| Report Source | OTHER,STUDY |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2017-03-03 |
| 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 | 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. Required No Informationntervention | 2020-01-09 |