MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-06 for ANCILLARY, SWEATBAND UL PLUS B AX1385BIF manufactured by Integra York, Pa Inc..
[138096415]
The device was not returned for evaluation. The lot number/serial number was not received to perform a device history record review. A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation. Product has not been returned. The reported complaint is unconfirmed. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[138096416]
A sales representative reported on behalf of the customer that the ax1385bif ancillary, sweatband ul plus b module has dimples on it. The heat melted the outside of the module. There was no patient contact, injury or surgery delay reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00035 |
| MDR Report Key | 8396831 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-13 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2018-09-25 |
| Date Added to Maude | 2019-03-06 |
| 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, SWEATBAND UL PLUS B |
| Generic Name | N/A |
| Product Code | FST |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-03-05 |
| Catalog Number | AX1385BIF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-06 |