MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-03-01 for XENMATRIX AB UNKAA105 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[137663323]
At this time, no conclusions can be made to what extent the bard/davol xenmatrix ab(device #2) may have caused or contributed to the reported event. The cause of the patient postoperative complications cannot be determined at this time. The patient's attorney alleges subsequent surgical intervention; however, no details have been provided. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. Information is limited. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol xenmatrix ab (device #2). An additional emdr was submitted to represent the bard/davol ventralex (device #1). Not returned.
Patient Sequence No: 1, Text Type: N, H10
[137663324]
The following was alleged by the patient's attorney: on (b)(6) 2016 or (b)(6) 2017: the patient underwent surgery for implant of an unspecified bard/davol ventralex (device #1) and unspecified bard/davol xenmartrixab (device #2). Ni/ni/ni:the patient had subsequent surgical intervention due to the hernia mesh device(s). The patient is making a claim for an adverse patient outcome against the bard/davol ventralex (device #1) and the xenmartrixab (device#2). The attorney alleges patient experienced emotional distress and the device was defective.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1213643-2019-01222 |
MDR Report Key | 8383863 |
Report Source | CONSUMER,OTHER |
Date Received | 2019-03-01 |
Date of Report | 2019-03-01 |
Date Mfgr Received | 2019-02-10 |
Date Added to Maude | 2019-03-01 |
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 | JAN LING |
Manufacturer Street | 100 CROSSINGS BLVD. |
Manufacturer City | WARWICK RI 02886 |
Manufacturer Country | US |
Manufacturer Postal | 02886 |
Manufacturer Phone | 8015652663 |
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 | SURGICAL MESH |
Product Code | PIJ |
Date Received | 2019-03-01 |
Model Number | NA |
Catalog Number | UNKAA105 |
Lot Number | NI |
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. Required No Informationntervention | 2019-03-01 |