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 2017-04-20 for XENMATRIX AB 1152020 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[73326632]
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.? Additionally, the adverse reaction section lists infection and fistula formation as potential complications. Dhr review found the device was supplied sterile to the customer with no anomalies noted during the manufacturing process. Based on the information provided and the patient's complex medical history, no conclusion can be made at this time. 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. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[73326633]
The following was reported and is part of a (b)(4) clinical study. In (b)(6) 2017 the patient was implanted with a xenmatrix ab graft. The patient presented to the clinic for her one month follow up visit on (b)(6) 2017. She presented with an intermittent fever and feculent and purulent secretions from the inferior pole of her midline incision and from her jp drains. She was admitted to the hospital and diagnosed with an abdominal abscess and fistula. Patient underwent ct guided drainage of the fluid collection. Approximately 10cc of sanguineous (bloody) fluid was obtained. Abdominal wound cultured and revealed bacterial growth. The abscess and fistula are both assessed as definitely related to the device and to the procedure. The patient? S outcome is currently listed as recovering and resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00257 |
| MDR Report Key | 6507792 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-04-20 |
| Date of Report | 2019-02-27 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2017-04-20 |
| 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 HEALTH CARE PROFESSIONAL |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-04-20 |
| Model Number | 1152020 |
| Catalog Number | 1152020 |
| Lot Number | HUAS0662 |
| Device Expiration Date | 2018-05-28 |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-04-20 |