MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-09 for AMNISURE FMRT-1 FMRT-1-25-CA manufactured by Amnisure International, Llc.
[4566577]
A complaint was received on (b)(4) 2013 regarding a pt who was at 23 weeks gestation and had been infertile for 10 years. She presented with leakage and was tested within 12 hours. The amnisure test was negative. She was discharged. Pt returned 24 hours later and the fetus had expired. Amniotic fluid was cultured and bacteria were present. No gross rupture was evident.
Patient Sequence No: 1, Text Type: D, B5
[12086570]
The company has evaluated this event and has determined that the result obtained from the device did not contribute or cause to the death of the fetus. However, the company has decided to submit this mdr for info purposes in an abundance of caution and to ensure full compliance with 21 cfr part 803. The company will supplement this mdr with additional info, as necessary. The healthcare facility reported unexpected negative results. The root cause for these results in undetermined however, the amnisure product instructions for use recommends that results should be used in conjunction with other clinical info. Failure to detect membrane rupture does not assure the absence of membrane rupture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2014-00005 |
| MDR Report Key | 3873848 |
| Report Source | 07 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-06-09 |
| Date Mfgr Received | 2013-09-10 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-06-17 |
| 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 | DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE |
| Generic Name | RAPID FETAL MEMBRANE RUPTURE TEST |
| Product Code | NQM |
| Date Received | 2014-06-09 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-CA |
| Lot Number | A2019 |
| Device Expiration Date | 2014-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMNISURE INTERNATIONAL, LLC |
| Manufacturer Address | 24 SCHOOL STREET, 6TH FLOOR BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-06-09 |