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 2018-03-07 for XENMATRIX AB 1151520 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[101694994]
There is no connection that can be made at this time between the reported post operative infection and any problem with the davol device used to treat the patient. The device is provided to the facility in a sterile state. Based on the information provided, a definitive cause for the patient's post operative infection is unknown. The patient's treatment continues at this time and the graft remains implanted. Infection is a known inherent risk of any surgical procedure. Regarding infection 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. " to date this is the only reported complaint for this production lot of (b)(4) units released for distribution in september, 2017. A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification should additional information be provided, a supplemental emdr 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
[101694995]
It was reported to davol that a patient who is part of a clinical study experienced a post operative infection. On (b)(6) 2018 - the patient underwent implant of the xenmatrix ab graft to repair a primary incisional hernia. The wound site was classified as clean with no existing infection. A retro-rectus without component separation technique was performed. There was a swiss cheese configuration (multiple discreet hernias) present. The total hernia defect was measured to be 15cm in length and 10cm in width. It was necessary to trim the graft and an overlap of 5cm was maintained around the hernia defect. The hernia was located in the subxiphoid, epigastric and umbilical area of the abdomen. Long-term absorbable monofilament suture was used with 12 fixation points. The midline fascia was completely closed and the skin was fully closed with staples. A drain was inserted in the left lower quadrant. On (b)(6) 2018 - removal of drain from the left lower quadrant. On (b)(6) 2018 - during a post operative visit the patient was diagnosed with an incision site infection. Also noted was a small area of erythema over the infraumbilical portion of the incision. No cultures were obtained. The patient was given a prescription for bactrim ds. The adverse event of post operatvie infection has been assessed as possibly related to the study device and definitely related to the procedure. There has been no surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00485 |
| MDR Report Key | 7319822 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-03-07 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-02-12 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2017-09-11 |
| Date Added to Maude | 2018-03-07 |
| 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 | 2018-03-07 |
| Model Number | NA |
| Catalog Number | 1151520 |
| Lot Number | HUBT0971 |
| Device Expiration Date | 2019-07-28 |
| 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 | 2018-03-07 |