MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-22 for PHASIX MESH NI 1190300 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[176112669]
Based on the information provided, no conclusion can be made at this time as to the cause of the post-op complication. As reported, the patient experienced inflammation which is listed as a known adverse reaction in the instructions-for-use. With no lot number provided, a review of the manufacturing records could not be conducted. With the information provided no conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[176112670]
It was reported that on (b)(6) 2018 the patient underwent autologous breast reconstruction surgery and a bard/davol phasix st mesh was implanted abdominally to help repair the removal of the patient's abd tissue. It is alleged about 16 months later on (b)(6) 2019 the patient underwent additional surgical procedure which included exploration of her abd wall due to increased swelling and discomfort. As reported, the surgeon noted the area to have severe inflammatory response to the phasix st mesh. As reported, the phasix st mesh was incorporated into the muscle and the surgeon removed a significant amount of scar tissue. Contact reports the patient continues having abd discomfort with working out and swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00493 |
| MDR Report Key | 9618042 |
| Report Source | CONSUMER |
| Date Received | 2020-01-22 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-08-23 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2017-12-28 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Model Number | NI |
| Catalog Number | 1190300 |
| Lot Number | HUBX0370 |
| Device Expiration Date | 2019-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-22 |