MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for DEROYAL PRUVENTOR M70-100L manufactured by Deroyal Industries, Inc..
[41417493]
Seven complaints (deroyal ref. No. (b)(4)) were filed at the same time from the same user facility ((b)(6)) for products with the same part number (m70-100l - heel protector, pruventor, long w/anti-rotation wedge) each reporting the same adverse event. A medical device report (mdr) is being filed for each complaint. The list of complaints and corresponding mdr is listed below. (b)(4) mdr no. 3010452421-2016-00001; (b)(4) mdr no. 3010452421-2016-00002; (b)(4) mdr no. 3010452421-2016-00003; (b)(4) mdr no. 3010452421-2016-00004; (b)(4) mdr no. 3010452421-2016-00005; (b)(4) mdr no. 3010452421-2016-00006; (b)(4) mdr no. 3010452421-2016-00007. Investigation findings: the investigation team followed up the initial report with additional questions. The questions are copied below. In addition, no complaint samples have been received by deroyal for analysis. Responses are listed below. We are still waiting for additional information. Where was location of the pressure ulcers: user facility stated that the pressure ulcer was on the back of the calf. We would like to verify when did each of these events occur: no response on this question from user facility. What type of patients did this happen with - ex. Elderly, young, middle age, diabetic: user facility responded that all patients with the pressure ulcers had spinal cord injuries. There was no information given as to any other or additional patient condition. Root cause: the investigation team is unable to determine a root cause. There are several factors that increase the formation of pressure ulcers. In this case, we do not have enough information to understand what caused the hospital acquired pressure ulcer. The customer/user facility has not responded to all of our inquiries. Also no sample were sent back for analysis. The intended use for this product is to "help prevent heel decubitus ulcer. " it is important the corresponding health professional to "read all instructions, warnings, and precautions before use. Correct application is essential for proper functioning of the product. " this is stated in the product's instructions for use (ifu). The ifu also instructs to the corresponding health care professional to "perform periodic skin assessment. " corrections: no corrections were necessary. Corrective action: no root cause was found. There is no corrective action needed at this time. Preventive action: no root cause was found. There is no preventive action needed at this time. 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
[41417494]
Copied below are responses given by the initial reporter to the deroyal complaint questionnaire. Quality issue details: date of occurrence: (b)(6) 2016. 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: patient developed hospital acquired pressure ulcer when using this product. How was the quality issue was identified: by actual use. How was the product being used: heel protector. 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: don't know. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: patient developed hospital acquired pressure ulcer. Additional request for information from customer. The investigation team followed up the initial complaint report with additional questions. The questions are copied below. At the time of this writing, no response was given my customer. In addition, no complaint samples have been received by deroyal for analysis. Where was location of the pressure ulcers; we would like to verify when did each of these events occur; what type of patients did this happen with - ex. Elderly, young, middle age, diabetic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010452421-2016-00002 |
| MDR Report Key | 5532617 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-02-29 |
| Report Date | 2016-02-29 |
| Date Reported to Mfgr | 2016-02-29 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2016-03-29 |
| 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 | DR. MARIAN VARGAS |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES, GUATEMALA 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL PRUVENTOR |
| Generic Name | HEEL PROTECTOR, PRUVENTOR, LONG W/ANTI-ROTATION WEDGE |
| Product Code | FMP |
| Date Received | 2016-03-29 |
| Model Number | M70-100L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-29 |