MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-02 for PREMIUM SIZED ABDOMINAL BINDER 13993000 28158 manufactured by Deroyal Industries, Inc.
[21122877]
The pt reported the following: "i have only had your product for a month and hardly used it and yet it is already falling apart. It is ripping from the seams, almost like a lady pantyhose. Seems like it's running apart from the seam. What concerns me is: i had my daughter order the same product in a smaller size (9 in med/lrg 46 in - 62 in). Did i just receive a bad item or is she too going to have an issue? I just received your product. I went with your item because it looked very similar to the hosp quality one i've had for years and now i have none at all to use because yours doesn't seem to be holding support of my hernia now that it is pulling from the seams. If i know this product wasn't going to hold up at the seams i would have kept my 8 year old binder because it still had more support than this one does. Thank you for your time. "
Patient Sequence No: 1, Text Type: D, B5
[21216705]
Corrective action and/or systemic correction action taken: investigation findings: mfg process. It was determined that machine (rd3) used to knit the binder raw material (b)(4) had an incorrect tension setting. It is an inherent to the knitting process that material feeds into the knitting machine. The machine adjustment involves an iteration of small adjustment on the tension, producing material and testing material to see if desired % stretch of elastic has occurred. If not the adjustment process is continued. Due to the nature of the knitting machine rd3 there are no specifications for the machine itself, only the resulting raw material. Product sewing / joining personnel. Incorrect joining may contribute to the binder ripping from the seams. There have not been changes in the current personnel who join the binders. A lot number was not provided; therefore, the person responsible for sewing the part could not be tracked down and no statistical analysis could be performed on personnel recurrence failure. Correction: not applicable, product was not returned for reprocess. Root cause analysis: it was identified that the raw material (b)(4) had a change in stretching due to the knitting machine rd3 needed to be adjusted. The machine was adjusted according the iterative process described in investigation findings section. The adjustments were documented using (b)(4). This form is attached to the complaint file in (b)(4). It was identified that the raw material (b)(4) had a change in stretching due to the knitting machine rd3 needing to be adjusted. The machine was adjusted according to the iterative process described in investigation findings section. The adjustments were documented using (b)(4). This form is attached to the complaint file. In order to address any possible sewing/joining errors that may have occurred, personnel were retrained on making sure to check all devices from an order have the joining of binders correctly done. The training was documented using (b)(4). This form is attached to the complaint file. A quality control inspection step was put into place in order to verify proper joining of binders and stretching of material is consistent with master samples (b)(4). The routing instructions for (b)(4) will be updated with what to do when the material stretch is not met. This will include instructions to perform material adjustments on machine rd3 for raw material (b)(4) and to document when adjustments were made. Analysis of whether additional preventive actions are needed is in progress. We will provide follow up report if additional info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010452421-2015-00006 |
| MDR Report Key | 4814466 |
| Report Source | 08 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-29 |
| Date of Event | 2015-05-07 |
| Date Facility Aware | 2015-05-07 |
| Report Date | 2015-05-09 |
| Date Mfgr Received | 2015-05-07 |
| Date Added to Maude | 2015-06-30 |
| 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 Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES 0000 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIUM SIZED ABDOMINAL BINDER |
| Product Code | FSD |
| Date Received | 2015-06-02 |
| Returned To Mfg | 2015-05-14 |
| Model Number | 13993000 |
| Catalog Number | 28158 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-02 |