MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-25 for XENMATRIX AB 1151010 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[106582925]
The doctor reporting the event reported that she wanted to make the manufacturer aware of this case. The hospital did not identify that the xenmatrix ab graft to be causing the complications experienced by the patient. At this time there is no connection that can be made between the reported post-op complication being caused by the xenmatrix ab graft. A manufacturing review that included review of sterility records was performed. No manufacturing issues associated to the reported event were found in the reviewed lot. Dhr review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used. All process steps were completed per manufacturing procedures and inspection procedures. Product passed all required inspections at both end product and subassembly levels. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in (b)(4) 2017. Infection is a known inherent risk of surgery. The warning section of the instructions-for-use states, "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. " risk manager reported that if/when an internal report is processed a copy would be sent davol. Should additional information be obtained, a supplemental emdr will be submitted. Note: 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
[106582926]
As reported, the patient is a (b)(6) boy who was born pre-term with significant medical complications. In 2015, the boy underwent a multi-visceral organ transplant. As reported, the patient rejected this organ transplant. In (b)(6) 2017 he underwent a second multi-visceral organ transplant procedure. During this procedure, a xenmatrix ab graft was implanted. The patient experienced post-op complications with fluid accumulation in the area of the graft. This was later identified as an infection at the site. The patient is reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01196 |
| MDR Report Key | 7459293 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2018-04-25 |
| 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 | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2018-04-25 |
| Model Number | NA |
| Catalog Number | 1151010 |
| Lot Number | HUBN0808 |
| Device Expiration Date | 2018-12-28 |
| 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 | 2018-04-25 |