MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-17 for HUGS 806A2001 NA manufactured by Stanley Security Solutions, Inc..
[17264139]
From medwatch form received from user facility: "per nurse coordinator on pediatrics: when you put the strap through the hugs tags, the strap curls and pulls apart; an rn pulled the strap out of a hugs tag and the alarm should have gone off and it didn't; there were multiple pts that this happened to. Also there were some from devices in this box of straps that worked fine. The unit has been using another box of straps with the same number that is stamped on the end of the box for two days and have had no issues. This issue has happened with multiple staff members. Customer service contacted and said i could not send it back. I had to leave a message with qa. " mfr followed up with facility. Statement that customer could not send it back was misleading. Mfr required return through dist for record-keeping purposes. Customer returned remaining samples through dist, which in turn processed a return to the mfr.
Patient Sequence No: 1, Text Type: D, B5
[17454130]
Reported device is not a med device as it is not used to treat, diagnose, cure, or mitigate a disease or condition of man. Device is part of a security sys to assist staff in preventing infant abduction. Items are packaged in boxes of (b)(4). No sample was returned showing the failure i. E. Separated straps. Approximately (b)(4) straps were returned from the suspect box and were tested by the mfr. Qual and functional tests were unable to reproduce any failure, including strap insertion tests on sample tags in an attempt to simulate use conditions between strap and tag resulting in failure. Additional follow up with facility has no far resulted in no further response. Mfr has requested info specific to tags that were in use when straps separated, to inspect production records and return and inspect any such tag, if found. User facility report did not include pt or device codes. Therefore, mfr was unable to detect any failure with returned straps. Although awaiting further info from the facility, mfr concludes that the reported failure to alarm was within the five minutes period after strap insertion. Per design when the strap is cut within the five minute period, the alarm will not sound. The sys gives this period to nursing staff to allow adjustment to tag and strap after initial insertion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1929691-2014-00002 |
| MDR Report Key | 4231945 |
| Report Source | 06 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-09-15 |
| Date Mfgr Received | 2014-09-18 |
| Date Added to Maude | 2014-11-13 |
| 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 | GINA BENNETT |
| Manufacturer Street | 4600 VINE ST |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal | 68503 |
| Manufacturer Phone | 4027429322 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUGS |
| Generic Name | INFANT SECURITY |
| Product Code | ILQ |
| Date Received | 2014-10-17 |
| Returned To Mfg | 2014-09-25 |
| Model Number | 806A2001 |
| Catalog Number | NA |
| Lot Number | 400082 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS, INC. |
| Manufacturer Address | LINCOLN NE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-17 |