MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-28 for PHASIX ST MESH UNKAA110 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[146255225]
Based on the information provided no conclusion can be made. Photos of the revision procedure were provided, however, review of the photos do not assist in identifying a root cause. Additional information was requested and the contact reported that no additional information would be provided. Hernia recurrence is a known inherent risk of hernia repair surgery. Regarding recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, phasix? St mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. " a lot number was not provided. Without a lot number a review of the manufacturing records is not possible. Should additional information be provided, a supplemental emdr will be submitted. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[146255226]
It was reported that approximately 12-14 months post robotic ipom procedure with the bard/davol phasix st mesh, the patient experienced a hernia recurrence. A revision procedure was performed on (b)(6) 2019. The phasix st mesh was removed and a synthetic mesh used. As reported during the index procedure the primary defect was closed with absorbable vlock suture (non bard/davol).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-04361 |
| MDR Report Key | 8646617 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-05-28 |
| 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 ST MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OWT |
| Date Received | 2019-05-28 |
| Model Number | NA |
| Catalog Number | UNKAA110 |
| Lot Number | NI |
| 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 | 2019-05-28 |