MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-21 for DR COMFORT 11300XL-SHORT manufactured by Djo, Llc.
[80669270]
Complaint received that alleges "allergic reaction to the color die of the stocking and broke out in hives. Patient was in the hospital for 4 days, out of the hospital and well now". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[109782033]
Product was returned for review. "conditions were evaluated visually: the product doesn't present any defects".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008579854-2017-00004 |
| MDR Report Key | 6731926 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-09-09 |
| Date Added to Maude | 2017-07-21 |
| 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 | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer G1 | DR COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DRIVE |
| Manufacturer City | MEQUON 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR COMFORT |
| Generic Name | ANTIEMB 18MMHG KN CT BLACK XL/SHORT |
| Product Code | DWL |
| Date Received | 2017-07-21 |
| Model Number | 11300XL-SHORT |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-07-21 |