MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-11-19 for AXOGUARD NERVE CONNECTOR AND PROTECTOR AG0320 manufactured by Cook Biotech.
[5009651]
On (b)(6) 2014, (b)(6) of (b)(6), performed a carpal tunnel release revision and trigger thumb release. An ag0320 was implanted. At an unspecified time post op, the patient developed redness and there was concern of infection. The patient was placed on a course of oral antibiotics. The patient had ongoing pain at the surgical site, redness, swelling, and drainage. On (b)(6) 2014, dr. (b)(6) colleague performed an incision and drainage due to concern of an infection. During this procedure axoguard was noted to have drainage present around it. The axoguard was removed and sent to pathology. The pathology report showed the presence of fibrinopurulent exudate and foreign body giant cells. As of (b)(6)2014, the patient reportedly has ongoing issues with infection at the wound site and has undergone an additional incision and drainage during the week of (b)(6) 2014. A wound culture was taken and sent out for evaluation. Results of this are not yet available.
Patient Sequence No: 1, Text Type: D, B5
[12578591]
Method and results: product not returned to cbi. Conclusions: root cause unlikely related to device; investigation ongoing. Investigation - evaluation: investigation into this feedback included a review of the feedback details, communication with axogen for follow-up with surgeon and case specific details, a review of the device history records which indicated the product was manufactured to specifications, and a review of the axoguard nerve protector ifu (b)(4). Summary of investigation findings: the root cause of the infection is unlikely related to the axoguard nerve protector. Infection is a known complication of any surgical procedure and is listed as a potential complication in the ifu. Additionally the ifu states that if an infection occurs and cannot be resolved, careful removal of the device should be considered. The investigation into this feedback is ongoing. A follow-up mdr will be filed as new details are received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1835959-2014-00980 |
| MDR Report Key | 4275618 |
| Report Source | 08 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-10-13 |
| Date Mfgr Received | 2014-10-24 |
| Device Manufacturer Date | 2014-01-22 |
| Date Added to Maude | 2014-11-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PERRY GUINN, VP |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXOGUARD NERVE CONNECTOR AND PROTECTOR |
| Generic Name | NERVE WRAP |
| Product Code | JXI |
| Date Received | 2014-11-19 |
| Catalog Number | AG0320 |
| Lot Number | LB722042 |
| Device Expiration Date | 2014-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-11-19 |