MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-23 for ANCILLARY, HEADBAND UL PLUS BI AX1375BIF manufactured by Integra York, Pa Inc..
[133937835]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[133937836]
It was reported that on (b)(6) 2018 the ax1375bif ancillary, headband/sweatband ul plus bi module went dim a few times before the plastic on the underside of the module overheated and melted. It is unknown if there was any patient contact, or a surgical delay, however, there was no patient injury/death alleged. Request for additional information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00013 |
| MDR Report Key | 8272769 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-23 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-23 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCILLARY, HEADBAND UL PLUS BI |
| Generic Name | N/A |
| Product Code | FST |
| Date Received | 2019-01-23 |
| Catalog Number | AX1375BIF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-23 |