MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2018-10-17 for PHASIX MESH 1190400 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[123961121]
No conclusion can be made. Based on the information provided at this time,we are unable to determine to what degree, if any, the mesh implant used to treat the patient may have caused or contributed to the recurrent hernia. Recurrence is a known inherent risk of hernia repair surgery with or without the use of mesh. Recurrence is listed in the adverse reaction section of the instructions-for-use as a possible complication. 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[123961122]
It was reported that a patient who is part of a clinical study (phasix dvl-he-011) experienced a hernia recurrence on (b)(6) 2014 - the subject patient underwent repair of a midline primary incisional hernia with the implant of a phasix mesh. This was a retro-rectus repair without component separation technique. Absorbable monofilament suture was used for fixation of the mesh. The fascia and skin were fully closed. On (b)(6) 2018 - the subject patient was diagnosed with a hernia recurrence. This adverse event has been assessed as mild severity, possibly related to the device and not related to the index procedure. No action has been taken at this time, condition is listed as ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-03581 |
| MDR Report Key | 7973590 |
| Report Source | OTHER,STUDY |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2013-11-13 |
| Date Added to Maude | 2018-10-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-17 |
| Model Number | NA |
| Catalog Number | 1190400 |
| Lot Number | HUXETP13 |
| Device Expiration Date | 2014-12-28 |
| 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 | 2018-10-17 |