MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for DRIGARD TOWELS WESCEBL manufactured by Crosstex International Inc..
[139956895]
Crosstex received a report through distributor, (b)(4). The report stated a facility reported that while using a crosstex drigard towel, the patient experienced an allergic reaction. Crosstex followed up with the facility for more information. It was reported the patient experienced symptoms of itchiness and redness on her skin at the contact site for several days. The user did seek medical attention and received steroid shots. It was reported the user's current condition is fine. Crosstex has not received any similar complaints related to the drigard towel. This complaint will continue to be monitored in the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[139956896]
The facility reported that while using a crosstex drigard towel, the patient experienced an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2019-00001 |
| MDR Report Key | 8453817 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-26 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 7632487189 |
| Manufacturer G1 | CROSSTEX INTERNATIONAL |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DRIGARD TOWELS |
| Generic Name | TOWEL |
| Product Code | KHR |
| Date Received | 2019-03-26 |
| Model Number | WESCEBL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Address | 10 RANICK ROAD HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-26 |