MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-15 for DEROYAL T700 manufactured by Deroyal Industries, Inc.
[126090819]
The reported incident indicates there was no report of injury. Ordinarily, deroyal would not consider this event reportable under 21 cfr 803. However, deroyal is voluntarily filing an mdr report for this quality issue because notification of a medwatch was received from the fda. The reported failure was "device is leaking at the connection hose". A lot number or batch number was provided on this complaint. The medwatch report states that the identification number is (b)(4). A sample has not been returned for evaluation due to the unit was not available for return. The quality specialist was unable to determine exact error or issue because testing could not be completed. Corporate corrective action preventive action (capa), (b)(4), was initiated and assigned to deroyal engineering, quality control and marketing to evaluate the reported issue of broken connector on the temperature therapy units. The true root cause of the reported issue is undetermined at this point of the investigation process. A corrective action has not been taken at this time. As more information becomes available on capa actions to be taken a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[126090820]
Quality issue details- date of occurrence: (b)(6) 2018. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Patient/end consumer. Was a medical procedure involved? Yes. Name of medical procedure: right total knee replacement. Did the quality issue cause a delay in the medical procedure? No (please provide length of delay and any other details about the procedure in the detailed description field below). Detailed description of quality issue: device is leaking at the connecting hose. How was the quality issue was identified? By actual use. How was the product being used? Therapy. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by deroyal? No. Was the product connected to or used in conjunction with other devices or equipment? No. Outcome details- outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: none. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? Yes - reported on (b)(6) 2018. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: patient had to return to hospital for a new unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2018-00008 |
| MDR Report Key | 7964834 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-15 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MELISSA LOGSDON |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1595 HWY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2018-10-15 |
| Model Number | T700 |
| Lot Number | 18001810 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC |
| Manufacturer Address | 1595 HWY 33 SOUTH NEW TAZEWELL TN 37825 US 37825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-15 |