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 2016-12-12 for XENMATRIX AB 1152020 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[62124400]
Based on the information provided and the patient's complex medical history, no conclusion can be made at this time. Infection is a known inherent risk of any surgical procedure, the warning section of the ifu states, "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. If additional information is provided, 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
[62124401]
It was reported to davol that a patient who is part of a clinical study experienced a post surgical site infection. As reported the patient, who has a highly complex medical history, underwent implant of the xenmatrix ab graft on (b)(6) 2016. Patient was evaluated at a follow up visit on (b)(6) 2016 in which the inferior half of the incision was noted to have surrounding induration and blanching erythema. The patient was diagnosed to have an abscess (rectorectus but anterior to mesh) on (b)(6) 2016. This ae has been defined as severe and possibly related to the device with prolonged hospitalization and additional medical/surgical intervention. One drain was placed in the right lower quadrant in the retro-rectus space on (b)(6) 2016. The patient was treated with iv antibiotics for a deep wound surgical site infection. Cultures were obtained and revealed bacterial growth of (b)(6) and enterobacter cloacae. No mesh infection was identified. There was noted to have been a dehiscence of the incisional wound. Treatment is ongoing at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2016-00568 |
| MDR Report Key | 6166220 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2016-12-12 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-11-29 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2016-12-12 |
| 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 | 2016-12-12 |
| Model Number | NA |
| Catalog Number | 1152020 |
| Lot Number | HUAS0662 |
| Device Expiration Date | 2018-05-28 |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-12-12 |