MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for GORE? BIO-A? HERNIA PLUG 1HPGNF04 manufactured by W.l. Gore & Associates.
[187922938]
The initial reporter's complete address is (b)(6). (b)(4). It should be noted that the gore? Bio-a? Hernia plug instructions for use includes warnings and addresses the following adverse reactions among others:? Possible adverse 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. The gore? Bio-a? Hernia plug instructions for use also states:? Strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material.
Patient Sequence No: 1, Text Type: N, H10
[187922939]
It was reported to gore that the patient underwent inguinal hernia repair on (b)(6) 2008 whereby a gore? Bio-a? Hernia plug was implanted. The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection, chronic pain and swelling abdomen. Additional event specific information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00086 |
| MDR Report Key | 9694210 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-10 |
| Date of Event | 2015-06-01 |
| Device Manufacturer Date | 2010-09-13 |
| Date Added to Maude | 2020-02-11 |
| 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 | JEFF MCQUERREY |
| 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 | GORE? BIO-A? HERNIA PLUG |
| Generic Name | MESH, SURGICAL, ABSORBABLE, ABDOMINAL HERNIA |
| Product Code | OWT |
| Date Received | 2020-02-11 |
| Model Number | 1HPGNF04 |
| Catalog Number | 1HPGNF04 |
| Lot Number | 8330851 |
| Device Expiration Date | 2013-06-30 |
| 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 | 2020-02-11 |