MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-05 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[177825962]
Based on the information provided, it is unclear what may be causing the reported condition of the mesh post implant. As reported this hernia has been repaired multiple times and the mesh was fixated "somewhat inside the edge. " the mesh has been implanted for a little over 6 months. Per the instructions-for-use absorption of the mesh material will be essentially complete within 12 to 18 months. As reported no additional intervention is planned at this time. A lot number was not provided; without a lot number a review of the manufacturing records is not possible. The cause cannot be determined. Should additional information be provided, a supplemental emdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[177825963]
It was reported that on (b)(6) 2019 the patient underwent the repair of a recurrent abdominal incisional ventral hernia repair. The patient has had this hernia repaired multiple times before. There were multiple defects 1-3 cm and a bard phasix mesh was used for the repair. The contact reports that the mesh was fixated "somewhat inside the edge. " the contact reports that 6 months post implant the lateral edge curved up and is sitting just below the dermis, and is visible through the skin and sticks out and is palpable as a hard linear mass. It is reported that the mesh has been placed for 6 months and is showing no signs of softening up. Currently, there is no intended intervention planned at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00903 |
| MDR Report Key | 9672218 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-04 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-02-05 |
| 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 MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2020-02-05 |
| Model Number | NA |
| Catalog Number | UNKAA091 |
| 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 | 2020-02-05 |