MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-26 for 3728LF TED STKG NYL T/L LR manufactured by Covidien.
[5518023]
It was to covidien on (b)(6) 2015 that a customer had an issue with a ted stocking. The customer reported on the (b)(6) 2015, a female patient had a breast vasectomy and diep at (b)(6). The patient had to wear the anti-embolism stockings as it is standard protocol at the facility. During the day of the surgical procedure and the next, the patient remained at the facility under a pain regime. The patient indicated during recovery and while awake, she did not feel pain in her breast or stomach, but pain on her legs where the t. E. D. Stockings were. Once the stockings were removed, there were 6 blisters 3 x 3 centimeters in size located under the top band of the t. E. D. Stocking. It was also reported the recovery of the original surgical procedure is going smoothly, but the patient had to stay in an extra day at hospital and is still on heavy pain regime for the blisters.
Patient Sequence No: 1, Text Type: D, B5
[12937820]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[24415929]
The product sample was received for evaluation and consisted of two t. E. D anti-embolism elastic stockings, thigh length, large regular, white, nonsterile. The stockings did not present signs of use. The lot number received on the sample was 1431900227. The device history record was reviewed indicating that product was released accomplishing all quality standard requirements. There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint. Photos were also received for evaluation. Blisters were observed on the upper area of the patient? S leg. Possible root causes could be due to improper sizing, the stocking may have been smaller than the required size or due to improper application of the stocking. Controls, such as in-process visual inspection, volume testing and compression testing, are in place to prevent non-conforming material from leaving the manufacturing process. According to the process specification ted stockings packaging, all the stocking packages include the insert document with the instructions for appropriate stockings application and use. The ted stockings products were submitted to cytotoxicity testing and skin irritation evaluation, meeting the requirements for intended use. A corrective action is not warranted at this time. It must be noted that in-process controls (personnel training, in-process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2015-00134 |
| MDR Report Key | 4551632 |
| Report Source | 04 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2015-06-02 |
| Date Added to Maude | 2015-02-26 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3728LF TED STKG NYL T/L LR |
| Generic Name | COMPRESSION STOCKING |
| Product Code | FQL |
| Date Received | 2015-02-26 |
| Model Number | 3728LF |
| Catalog Number | 3728LF |
| Lot Number | NI |
| 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 | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-26 |