MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-23 for DEROYAL 4302B manufactured by Deroyal Industries, Inc..
[68212138]
The complaint call reported skin break down. There were no other details provided. No sample was returned. Sales representative has attemped to obtain more details from customer and has not been successful. Without any further information, the investigation team is unable to determine root cause. This is one of three complaints that came in at the same time for the same line of product from the same user facility. Complaint history between 01-01-2012 to 12-30-2016 was reviewed. There are no other skin breakdown complaints. No further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[68212139]
Quality issue details: date of occurrence: (b)(6) 2017; 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: no; detailed description of quality issue: skin break down with boot; how was the quality issue was identified: by actual use; how was the product being used: for positioning / pressure reduction; 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: other; person(s) affected by outcome(s) checked above: none; known pre-existing condition(s) of person(s) affected: skin breakdown; was the incident reported to the fda: no.
Patient Sequence No: 1, Text Type: D, B5
[70583594]
The complaint call reported skin break down. There were no other details provided. No sample was returned. Sales representative has attempted to obtain more details from customer and has not been successful. Without any further information, the investigation team is unable to determine root cause. This is one of three complaints that came in at the same time for the same line of product from the same user facility. Complaint history between 01-01-2012 to 12-30-2016 was reviewed. There are no other skin breakdown complaints. No further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[70583595]
Quality issue details: date of occurrence: (b)(6) 2017. 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? No. Name of medical procedure: not applicable. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: skin break down with boot- how was the quality issue was identified? By actual use. How was the product being used? For positioning / pressure reduction. 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: other. Person(s) affected by outcome(s) checked above: none. Known pre-existing condition(s) of person(s) affected: skin breakdown. Was the incident reported to the fda? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2017-00005 |
| MDR Report Key | 6354170 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-23 |
| Date of Report | 2017-01-26 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-01-26 |
| Date Added to Maude | 2017-02-23 |
| 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 | MS. ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO, DOMINICAN REPUBLIC |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | ANKLE CONTRACTURE BOOT |
| Product Code | ITW |
| Date Received | 2017-02-23 |
| Model Number | 4302B |
| Operator | LAY USER/PATIENT |
| 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 | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 SANTIAGO, DOMINICAN REPUBLIC DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |