MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-05 for URI DRAIN IND W/STRAP 8884732300 manufactured by Covidien Lp, Formerly Registered As Kendall Kenmex.
[3193591]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a uri drain. The customer reported that they have used this product for many years and is now having a reaction to them. The customer reports having a reaction causing redness, blisters that have popped and is now raw red. The patient was seen at his doctor? S office and was prescribed bactroban cram and sipro antibiotics 500 mg to be taken twice a day. He is revisiting his doctor as no improvement to the condition has been made with the antibiotics, and the discontinuance of the device.
Patient Sequence No: 1, Text Type: D, B5
[10564722]
Submit date: (b)(4) 2013. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2013-00005 |
| MDR Report Key | 2997564 |
| Report Source | 04 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-02-12 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-03-22 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON SELBY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL KENMEX |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URI DRAIN IND W/STRAP |
| Generic Name | URI DRAIN |
| Product Code | NNZ |
| Date Received | 2013-03-05 |
| Returned To Mfg | 2013-02-22 |
| Model Number | 8884732300 |
| Catalog Number | 8884732300 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL KENMEX |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-05 |