FDA Adverse Event
Other
Summary report: N
MOTHERMATES HYDROGEL BREAST PAD INTNL
MDR report key: 3878064
·
Received June 3, 2014
Report
- Report Number
- 1219103-2014-00013
- Event Type
- Other
- Date Received
- June 3, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 16, 2014
- Manufacturer
- COVIDIEN
- Product Code
- MGQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BREAST PAD. THE CUSTOMER STATES THAT DURING THE REMOVAL OF THE FOIL, THE PADS RIP LEAVING SMALL RESIDUAL PIECES ON THE FOIL AND SOMETIMES ON THE PATIENT'S BREAST. AN INFANT HAD SMALL PARTS OF THE PAD IN ITS MOUTH. ALSO, THE SHEET GETS POROUS AFTER ABOUT THREE DAYS OF USE. THE DURATION OF USE WAS TWO DAYS. THERE WERE NO CONSEQUENCES TO THE PATIENT AS A RESULT. NO ALLERGIC REACTION AND THE PIECES WERE REMOVED FROM THE INFANT'S MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325281 | MOTHERMATES HYDROGEL BREAST PAD INTNL | BREAST PAD | MGQ | COVIDIEN | 9403 | 317806X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |