FDA Adverse Event
Injury
Summary report: N
DAVOL SILICONE ROUND SINGLE DRAIN
MDR report key: 3779141
·
Received April 17, 2014
Report
- Report Number
- 1018233-2014-00083
- Event Type
- Injury
- Date Received
- April 17, 2014
- Date of Event
- March 14, 2014
- Report Date
- March 26, 2014
- Manufacturer
- PRODUCTOS PARA EL CUIDADO DE LA SALUD
- Product Code
- GBX
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2014 THE DRAIN WAS PLACED FOR A HIP OPERATION. ON (B)(6) 2014 WHEN THE DRAIN WAS REMOVED SLOWLY FROM THE PATIENT, THE DISTAL END OF THE TUBE (APPROXIMATELY 32MM) WAS FOUND TO BE TORN OFF. THE TUBE SEGMENT WAS REMOVED FROM THE PATIENT'S BODY VIA A SURGICAL OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236295 | DAVOL SILICONE ROUND SINGLE DRAIN | GBX | PRODUCTOS PARA EL CUIDADO DE LA SALUD | NA | NGXH6757 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |