MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-26 for V-APC 60-01 manufactured by Harvest Technologies, Corp..
[18541834]
The customer reported that a patient (giant american thoroughbred) underwent intra-lesional platelet-rich plasma (prp) therapy for tendinopathy of the deep digital flexor tendon in the mid-metatarsal regional of the left hind. Two days later, the patient was found to be acutely lame on the left hind and the limb was swollen at the fetlock. An ultrasound on (b)(6) 2014 showed further tendon deterioration and tendon sheath effusion. His condition continued to decline despite laser treatments, cold therapy and leg wraps. The customer is alleging the event is a result of either a reaction to the v-apc 60-01 product or the patient experienced a severe infection related to the prp injection process. He was confined to stall rest and started on a 10 day course of trimethoprimsulfamethoxazole twice daily, as well as a 10 day course of iv gentamicin sulfate. Equine information: id - (b)(6), male, born in 1999, weight is not available. This report is being filed due to equine patient injury using a device platform that is similarly marketed within the us for human use.
Patient Sequence No: 1, Text Type: D, B5
[18815488]
Per the vet report, the patient was confined to stall rest on (b)(6) 2014 and started on a 10 day course of trimethoprim-sulfamethoxazole twice daily, as well as a 10 day course of iv gentamicin sulfate. On (b)(6) 2014, additional radiograph and ultrasound showed significant deterioration of the left deep digital flexor tendon. Amikacin was injected into his left hind tendon sheath on (b)(6) 2014. Bacterial infection from the prp injection cannot be ruled out as a possible contributing factor. Infection could have been the result of introduction of bacteria from his skin and hair or from contaminated product. Prp injection can result in localized inflammation, and inflammation can lead to damage of the tendon, although the degree of reaction the patient exhibits is uncommon. On (b)(6) 2014, a recheck ultrasound was performed and the tendinitis had not worsened. By (b)(6) 2014, the patient was able to maintain a comfortable walk. The injury may take up to 12 months before it is healed. Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225520-2014-00002 |
| MDR Report Key | 4364645 |
| Report Source | 05 |
| Date Received | 2014-11-26 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-10-28 |
| Device Manufacturer Date | 2014-06-26 |
| Date Added to Maude | 2014-12-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES BAUER |
| Manufacturer Street | 40 GRISSOM RD, SUITE 100 |
| Manufacturer City | PLYMOUTH MA 02360 |
| Manufacturer Country | US |
| Manufacturer Postal | 02360 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-APC 60-01 |
| Generic Name | PRP PROCESSING KIT, EQUINE |
| Product Code | ORG |
| Date Received | 2014-11-26 |
| Model Number | V-APC 60 |
| Catalog Number | V-APC 60 |
| Lot Number | VA60-01-0032 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARVEST TECHNOLOGIES, CORP. |
| Manufacturer Address | PLYMOUTH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-26 |