MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-28 for DARCO HS1005-12 manufactured by Darco International, Inc..
[48407550]
Investigation findings: the complaint sample was returned. (b)(4) does not manufacture this product. This product is manufactured by darco international, inc. , and purchased by (b)(4). The product returned was labeled as hs1005-12 post-op shoe, orthowedge. However the product in the package was not a hs1005-12 post-op shoe, orthowedge. The boxes contained were heel wedge shoes. (b)(4) does not purchase or sell the heel wedge shoes. The vendor apparently shipped the product, referred in the complaint, to (b)(4) as ortho wedge shoes, but the product boxes actually contained another product (heel wedge shoes). All inventory at the (b)(4) processing center was evaluated and no incorrect product was identified. All inventory at the (b)(4) distribution center was evaluated and no incorrect product was identified. We were unable to confirm, nor do we have any indication to believe that the entire shipment on this (b)(4) purchase order was mis-labeled. We believe that it is possible, the manufacturer pulled an incorrect part from their inventory to include with our (b)(4) purchase order. All orthowedge product which was supplied to (b)(4) on the reported purchase order was shipped to customers as of october 2015. There have been no other reports of this nature. We believe this to be an isolated incident. This reported incident and product mis-labeling has been reported to the manufacturer, which is our supplier (b)(4). At this time we are taking no action with other parts distributed by (b)(4) into commercial distribution. We are not the manufacturer of this device, we are a distributor. We have been made aware of an isolated incidence where the manufacturer provided one part labeled as an orthowedge however inside the part was a heelwedge. Root cause: package mislabeling by manufacturer. Corrections: replacement product was requested and sent. Corrective action: this reported incident and product mis-labeling has been reported to the manufacturer, which is our supplier (b)(4). At this time we are taking no action with other parts distributed by (b)(4) into commercial distribution. We are not the manufacturer of this device, we are a distributor. We have been made aware of an isolated incidence where the manufacturer provided one part labeled as an orthowedge however inside the part was a heelwedge. Preventive action: no preventive action is required 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
[48407551]
The quality issue details and the outcome details section 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: incorrect product placed into packaging. How was the quality issue was identified? By visual inspection. How was the product being used? It was applied to patient. 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: required medical attention to prevent impairment details of medical attention required to prevent impairment: patient developed a complication due to the incorrect product. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: none. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: the patient was a post operative. She was placed in the incorrect shoe and soon after required additional surgery due to the fact that she was weight bearing on the wrong aspect of the foot.
Patient Sequence No: 1, Text Type: D, B5
[54907780]
The complaint sample was returned. Deroyal does not manufacture this product. It is manufactured by darco international, inc. , and purchased by deroyal. Deroyal has received the supplier corrective action request report from the vendor. The investigation report from supplier is attached. The vendor reported that inventory in stock was investigated to ensure issue was not present in their current inventory. Deroyal found the supplier investigation taken was found to be acceptable. The supplier has made their factory aware of the issue and requested that the factory add additional supervision and scrutiny in their outgoing packaging area. The supplier then verified effectiveness by increasing inspection level from 0. 65 aql s-1 to 0. 65 aql s-4 for 6 shipments, to determine if non-conformances discovered during that time to see if the higher level on inspection was needed. 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
| Report Number | 1060680-2016-00013 |
| MDR Report Key | 5756428 |
| Date Received | 2016-06-28 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-05-24 |
| Date Facility Aware | 2016-05-24 |
| Report Date | 2016-05-30 |
| Date Reported to Mfgr | 2016-05-30 |
| Date Mfgr Received | 2016-05-30 |
| Date Added to Maude | 2016-06-28 |
| 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 | DARCO INTERNATIONAL, INC. |
| Manufacturer Street | 810 MEMORIAL BLVD |
| Manufacturer City | HUNTINGTON WV 25701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 25701 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DARCO |
| Generic Name | ORTHOWEDGE PORT-OP SHOW |
| Product Code | IPG |
| Date Received | 2016-06-28 |
| Returned To Mfg | 2016-06-10 |
| Model Number | HS1005-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DARCO INTERNATIONAL, INC. |
| Manufacturer Address | 810 MEMORIAL BLVD HUNTINGTON WV 25701 US 25701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-28 |