MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-07-22 for AXOGUARD NERVE CONNECTOR AND PROTECTOR UNK manufactured by Cook Biotech.
[3689551]
On (b)(4) 2013, we rec'd notification from an (b)(6) rep that they had rec'd a complaint concerning the axoguard product (unconfirmed product code or lot number). At (b)(6), pt apparently had two (unconfirmed) axoguard products implanted to repair a nerve (believed to be two separate surgeries, and original implant and a revision, but this is also unconfirmed). The pt apparently had a reaction to both axoguard products and the hospital was inquiring if they could implant another axoguard product. There was evidence on mri of inflammation. (b)(6) instructed the facility that implantation of another axoguard was not advised as it appeared that the pt was reacting to the axoguard. (b)(6) was planning to gather add'l info from user facility. As of (b)(6) 2013, the surgeon had seen the pt again. On (b)(6) 2013, cbi was made aware that as of (b)(6) 2013, the surgeon did not have cultures back and was not sure what was the cause of the apparent inflammation. The surgeon indicated that lots of eosinophils were present. The surgeon indicated this observation was out of the ordinary. The surgeon had not seen the pt lately and all seemed to be okay. On (b)(6) 2013, an (b)(6) sales rep reported that the surgeon had not seen the pt again and the surgeon indicated that no add'l f/u was needed from (b)(6). The (b)(6) rep indicated it was unlikely that any further info regarding the event or pt would be rec'd from the surgeon. On (b)(6) 2013, the (b)(6) rep relayed to cbi that they had confirmed (verbally) that the pt did have axoguard product taken out after an initial implant, but was still uncertain if a separate surgery to remove the implant was performed or if the implant was removed during a revision surgery. In addition the wound bed was being treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[10960440]
Product manufacture date unk as lot number not provided by the complainant. Ec conclusions: root cause inconclusive due to lack of details provided by the complainant. Investigation into this report has included a review of the feedback details rec'd, communication with the (b)(4) rep to verify/clarify and gather add'l details, a review of the axoguard nerve protector ifu fp0067-01d and the axoguard products(s) performance and the resulting inflammation remains unk. A root cause of the reported inflammation is inconclusive due to lack of details. Both the axoguard nerve connector ifu fp0068-01d and the axoguard nerve protector ifu fp0067-01d. Potential complications note that "if any of the following conditions occur and cannot be resolved, careful removal of the device should be considered: infection, allergic reaction, and acute or chronic inflammation (initial application of surgical graft materials may be associated with transient, mild, localized inflammation). If/when add'l info is obtained, that alters our conclusion to this complaint, a f/u mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1835959-2013-00049 |
| MDR Report Key | 3245101 |
| Report Source | 08 |
| Date Received | 2013-07-22 |
| Date of Report | 2013-07-22 |
| Date Mfgr Received | 2013-06-24 |
| Date Added to Maude | 2013-07-25 |
| 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, QA/RA |
| 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 CUFF/ NERVE WRAP |
| Product Code | JXI |
| Date Received | 2013-07-22 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2013-07-22 |