MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-16 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[114138682]
Based on the information provided we are unable to determine to what extent, if any, the phasix mesh may have caused or contributed to the events as alleged. When asked, the contact would not provide his name and no contact information was given. As such we are unable to request additional information at this time. A lot number was not provided, without this information a review of the manufacturing records is not possible. Note the date of implant is an estimate as the actual date was not provided. Should additional information be provided, this report will be updated. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[114138683]
It is alleged that in (b)(6) 2018 the patient was implanted with a davol phasix mesh during an inguinal repair procedure. As reported following surgery the patient started taking enzymes because they "help break down scar tissue. " contact alleges a burning sensation in the area of the repair since implant and that the burning has increased since stopping the enzymes, one month ago. The contact reports the "skin is not red or oozing. " the patient has a doctors appointment scheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02402 |
| MDR Report Key | 7691888 |
| Report Source | CONSUMER |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-06-25 |
| Date Added to Maude | 2018-07-16 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| 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 | 2018-07-16 |
| 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 | 2018-07-16 |