FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2143008
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04735
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2011
- Report Date
- June 2, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED OVERDOSE AND UNDERDOSE SYMPTOMS OF INCREASED TONE, PRURITUS, AND FEVER. A CATHETER BREAK AND KINK WERE REPORTED. THE LOCATION OF THE ISSUE WAS AT THE "PROXIMAL/DISTAL CONNECTION." THE PT OUTCOME WAS REPORTED AS "NO INJURY". THE MEDICATION ON THE PUMP...
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Other |