MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-16 for HUBLESS SILICONE FLAT DRAIN 0070430 manufactured by Productos Para El Cuidado De La Salud.
[5394221]
It was reported that during the removal of the device, the white piece had become disconnected from the clear tubing and remained inside the patient. The patient was then taken to the operating room where she underwent an additional surgery to remove the piece left behind. The facility reports the tubing was not broken but came apart.
Patient Sequence No: 1, Text Type: D, B5
[12855830]
The sample was not returned for eval. The lot number is unk; therefore, the device history record could not be reviewed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2015-00009 |
| MDR Report Key | 4435900 |
| Report Source | 06 |
| Date Received | 2015-01-16 |
| Date of Report | 2014-12-22 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-12-22 |
| Date Added to Maude | 2015-01-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY LEWIS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| 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 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUBLESS SILICONE FLAT DRAIN |
| Product Code | GBY |
| Date Received | 2015-01-16 |
| Model Number | NA |
| Catalog Number | 0070430 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-01-16 |