MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-04 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[129296352]
Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. Multiple attempts have been made requesting additional information. At this time no conclusions can be made. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Pain, erosion and extrusion are listed in the adverse reaction section of the instructions-for-use as possible complications. Should additional information be provided, an emdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[129296353]
The following was reported via maude event report mw5081007: "a mesh called phasix was used in hernia and stomal prolapse to fix it. The weak area of skin began to erode, and the mesh is visibly coming out of my abdomen between the belly wall and the stoma. It? S touching and has stoma misshapen. It makes the skin where the stoma was created rip scar and bleed. The dr says 52 weeks until its gone. It horribly painful and prevents me from doing a lot of things i want to do. I have photos from surgery day one up to now. They show progression of mesh exposure from surgery (b)(6) 2018 if you would like them or to view them, please call me at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-04377 |
| MDR Report Key | 8130820 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2018-12-04 |
| 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 | 2018-12-04 |
| 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; 2. Deathisabilit | 2018-12-04 |