MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-02 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[174179026]
No conclusion can be made. As reported the patient has a complex surgical history and the information provided is limited. As such we are unable to determine the degree to which the mesh implant may have caused or contributed to the reported hernia recurrence. Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the instructions-for-use as a possible complication. A lot number was not provided; without a lot number a review of the manufacturing records is not possible. Note the date of event and date of implant are estimated based on the information provided. Should additional information be provided, a supplemental emdr will be submitted. This emdr represent the bard phasix mesh (device #1) an additional emdr was submitted to represent the bard phasix mesh (device # 2) remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[174179027]
It was reported that the patient had stage 3 bladder cancer in which his bladder was removed and a nephrostomy bag was placed. The patient subsequently developed an abdominal hernia. In 2017 the patient underwent repair of the ventral abdominal hernia with implant of a bard phasix mesh (device # 1). In (b)(6) 2018 the patient underwent repair of a recurrent hernia with implant of a second bard phasix mesh (device # 2). The previous phasix mesh (device #1) was not removed at this time. As reported, the patient is experiencing extreme pain and has a "bubble" where the mesh is located. The patient underwent an ultrasound recently but had not yet received the results. As reported, the pain has prevented the patient from working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00003 |
| MDR Report Key | 9539784 |
| Report Source | CONSUMER |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date of Event | 2018-04-15 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| 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 | 2020-01-02 |