N
Patient 1
INVESTIGATION OF THIS ISSUE AND THE RECALL ACTIVITIES FOR THESE LOTS ARE IN PROGRESS. FDA WILL BE NOTIFIED UPON ADDITIONAL INFORMATION AVAILABLE.
MAUDE MDR 6324309
- MDR report key
- 6324309
- Report number
- 3004068499-2017-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-08
- Date received
- 2017-02-10
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. PJ PARDO
- Address
- ONE PIERCE PLACE SUITE 475W ITASCA IL 60143 US
- Phone
- 847-847-8478
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | SPS-1 STATIC PRESERVATION SOLUTION | SPS-1 (UW SOLUTION) | ORGAN RECOVERY SYSTEMS, INC | KDN | SPS-1_2L | SPS-1_2L | PBR-0074-337 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-10 | 0 | 1. O |
Event Narratives#
D
Patient 1
FOUR COMPLAINTS WERE RECEIVED FROM CUSTOMERS WHO OBSERVED A "STRANGE ODOR" "EMANATING FROM THE SOLUTION" FROM SPS-1 (STATIC PRESERVATION SOLUTION) SOLUTION BAGS AND THE SOLUTION ITSELF. RELATED ORS(ORGAN RECOVERY SYSTEMS, INC.) COMPLAINT NUMBERS: RMA-002039, RMA-002080, RMA-002144, RMA-002150. LOTS INVOLVED: SPS-1_1L: PBR-0060-392, SPS-1_1L: PBR-0060-386. SPS-1_2L: PBR-0074-330, SPS-1_2L: PBR-0074-337. IN CASES WHERE THE 1L AND 2L WERE INCLUDED IN THE COMPLAINT, THE CUSTOMERS WEREN'T SURE WHICH BAG THE ODOR WAS COMING FROM. AFTER INITIAL INVESTIGATION IT IS CONFIRMED THAT THE DEVICE IS MALFUNCTIONED. COMPLAINTS WERE DETERMINED TO BE POTENTIALLY REPORTABLE. ORS MANAGEMENT DECIDED TO INITIATE A VOLUNTARY PRODUCT RECALL IN PARALLEL WITH THE INVESTIGATION. THE FDA (B)(4) OFFICE AND FDA (B)(4) OFFICE WAS NOTIFIED OF THE INITIAL ACTIONS FOR LOTS PBR-0060-392 AND PBR-0074-330 ON (B)(6) 2016. COMMUNICATION WITH THE FDA CONTINUED THROUGHOUT THE INVESTIGATION AS THE ADDITIONAL COMPLAINTS WERE RECEIVED AND ADDITIONAL ACTIONS TAKEN. DATE COMPLAINT RECEIVED FOR LOT PBR-00674-337: (B)(6) 2017. FDA RECALL NUMBER: Z-1111-2017.