MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-12-27 for ARCHITECT HMT-036F-FX manufactured by Harbor Medtech, Inc..
[63337196]
Due to the lack of patient and product information, and most importantly, any laboratory testing confirming bacterial contamination of the product, the root cause of the event is unknown. The device was not returned to the manufacturer and thus no additional testing could be performed. Review of the lot records indicated that the device met all acceptance criteria including sterility prior to release. We are unable to confirm the origin of the infection from the time in which the sterile pouch was opened to the time in which the device was removed from the patient.
Patient Sequence No: 1, Text Type: N, H10
[63337197]
Physician reported that the device was placed on a patient, worked "ok" but at the one-week follow-up visit had to be removed due to pseudomonas overgrowth. The graft was purportedly disposed. Manufacturer contacted physician who stated that the patient did "well", had no infection, and the device did not harm the patient. No laboratory tests were performed. Subsequent attempts, including direct written inquiries, were made to obtain patient-level information; however, physician was either unwilling or unable to provide additional information. When asked to provide specific detail on the patient and the event, the physician responded, "this was not an adverse event" and has since not responded to further attempts to gain additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010097129-2016-00001 |
| MDR Report Key | 6206707 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-12-27 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-06-30 |
| Date Mfgr Received | 2016-11-29 |
| Device Manufacturer Date | 2016-03-11 |
| Date Added to Maude | 2016-12-27 |
| 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 | STEVE PRIOLO |
| Manufacturer Street | 4 JENNER, SUITE 190 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496794800 |
| Manufacturer G1 | HARBOR MEDTECH, INC. |
| Manufacturer Street | 4 JENNER, SUITE 190 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT |
| Generic Name | COLLAGEN WOUND DRESSING |
| Product Code | KGN |
| Date Received | 2016-12-27 |
| Model Number | HMT-036F-FX |
| Lot Number | 036F160311B |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARBOR MEDTECH, INC. |
| Manufacturer Address | 4 JENNER, SUITE 190 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-27 |