MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for UNKNOWN manufactured by W.l. Gore & Associates.
[144244372]
(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:? 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
[144244373]
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2006, whereby an alleged gore device was implanted. The complaint alleges that on an unknown date, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh revision surgery, additional surgery, pain, bowel obstruction. Additional event specific information and medical records have been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2019-00320 |
| MDR Report Key | 8583069 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-05-14 |
| Date Added to Maude | 2019-05-06 |
| 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 | DAMON JACKSON |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | 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 | 0 |
| Brand Name | UNKNOWN |
| Product Code | OWT |
| Date Received | 2019-05-06 |
| Lot Number | UKN |
| 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 | 2019-05-06 |