FDA Adverse Event
Other
Summary report: N
XEROFRM GZE 4X3YD RL FOIL PK STRL
MDR report key: 2831319
·
Received November 2, 2012
Report
- Report Number
- 1018120-2012-00018
- Event Type
- Other
- Date Received
- November 2, 2012
- Report Date
- October 8, 2012
- Manufacturer
- COVIDIEN
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING CONTACTED THE CUSTOMER REQUESTING ADD'L INFO. ATTEMPTS WERE MADE TO RETRIEVE ADD'L INFO. HOWEVER, THE CUSTOMER REPORTS NO OTHER INFO OF THE EVENT IS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A PETROLATUM GAUZE. THE CUSTOMER REPORTS THAT UPON REMOVING THE DRESSING FROM A WOUND, SOME FIBERS REMAINED IN THE WOUND. THE CUSTOMER FURTHER REPORTS, THAT THE FIBERS WERE REMOVED IMMEDIATELY WITH NO ILL EFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XEROFRM GZE 4X3YD RL FOIL PK STRL | PETROLATUM GAUZE | FRO | COVIDIEN | 8884432000 | 120001762262X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |