FDA Adverse Event
Malfunction
Summary report: N
PRIME PLUS (R) BARIATRIC MATTRESS
MDR report key: 4190160
·
Received September 18, 2014
Report
- Report Number
- 3007538326-2014-00103
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 25, 2014
- Report Date
- September 17, 2014
- Manufacturer
- PRIMUS MEDICAL LLC
- Product Code
- IKY
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- Z-2596-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON REVIEW OF THE PICTURES OF THE MATTRESS SENT FROM THE CUSTOMER, THE URETHANE COVER BUBBLED AT THE CTR OF THE MATTRESS EXPOSING THE INSIDE OF THE TOP COVER OF THE MATTRESS. A NEW MATTRESS WAS SENT OUT TO THE CUSTOMER ON (B)(6) 2014. THIS PROBLEM HAS BEEN ASSIGNED TO CAPA #(B)(4), AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CORRECTIVE ACTION.
Description of Event or Problem · 1
UPON RECEIPT OF THE RECALL PACKET, THE CUSTOMER NOTIFIED THE FIRM THAT THEY HAD A DELAMINATED MATTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577745 | PRIME PLUS (R) BARIATRIC MATTRESS | IKY | PRIMUS MEDICAL LLC | PPBM427 | 032713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |