MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2015-06-26 for MALECOT FOUR-WING LATEX DRAIN 086026 manufactured by Productos Para El Cuidado De La Salud.
[17341000]
It was reported that the user has a latex allergy and his doctor inserted the latex malecot drain approximately three months ago as a feeding tube and the area around where the tube is inserted has become red and ulcerated; the doctor advised the patient's caretaker to apply a prescription zinc cream she already had on hand and is waiting to see how the ulcerated area responds. It is unknown at this time whether or not the ulcers are due to a latex allergy or a moisture issue where the tube is inserted.
Patient Sequence No: 1, Text Type: D, B5
[17421974]
No physical sample was returned, a picture was used for evaluation. Per visual evaluation the funnel and the shaft part of the catheter did not present damage or defects. The reported event was confirmed as user related. The lot number is unknown therefore a device history record could not be reviewed. (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2015-00206 |
| MDR Report Key | 4877645 |
| Report Source | 00,04 |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-03 |
| Date Mfgr Received | 2015-06-03 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY LEWIS |
| Manufacturer Street | 8195 INDUSTRIAL BOULEVARD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALECOT FOUR-WING LATEX DRAIN |
| Product Code | FEW |
| Date Received | 2015-06-26 |
| Model Number | NA |
| Catalog Number | 086026 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Manufacturer Address | NOGALES, SONORA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-26 |