MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for UNKNOWN manufactured by W.l. Gore & Associates.
[117259551]
(b)(4). Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. The initial reporter's complete address is: (b)(6). It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore? S eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others:? Strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material.? ? Possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.?
Patient Sequence No: 1, Text Type: N, H10
[117259552]
It was reported to gore that the patient underwent ventral hernia repair on (b)(6) 1997, whereby an alleged gore device was implanted. The complaint alleges that on (b)(6) 2015, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: hernia recurrence, extensive adhesions, chronic draining abdominal wall sinus, abscess, open draining wound, additional surgeries to repair hernia, mesh infection, mesh removal, loss of consortium. Additional event specific information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2018-00478 |
| MDR Report Key | 7788218 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-10 |
| Date of Event | 2015-07-29 |
| Date Added to Maude | 2018-08-16 |
| 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 | KATHY TITUS |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL WOODY MOUNTAIN B/P |
| Manufacturer Street | 3750 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | OWZ |
| Date Received | 2018-08-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-16 |