MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2017-02-06 for XENMATRIX AB 1152025 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[66656607]
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 patient post operative diarrhea. A probiotic regimen was recommended as treatment and the patient condition is reported to be resolving. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be reported regarding the patient's condition, a supplemental mdr will be submitted. 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
[66656608]
The following was reported and is associated with the phasix study dvl-he-012. On (b)(6) 2016 - the patient was implanted with a bard xenmatrix ab graft. On (b)(6) 2016 - the patient presented for follow up visit. The patient reports post operative diarrhea occurring roughly 2-3 days /week. A probiotic regimen was recommended (at least 1oz of kefir/yogurt for next 2 months). Outcome is reported as "resolving" and the patient states that she is getting better. This event was assessed as possibly related to the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00077 |
| MDR Report Key | 6305675 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-06 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2017-02-06 |
| 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 BERG |
| 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 | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-02-06 |
| Model Number | NA |
| Catalog Number | 1152025 |
| Lot Number | HUZL0467 |
| Device Expiration Date | 2017-12-31 |
| 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. Other | 2017-02-06 |