MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-06-03 for MOTHERMATES HYDROGEL BREAST PAD INTNL 9403 manufactured by Covidien.
[4564158]
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.
Patient Sequence No: 1, Text Type: D, B5
[12018835]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219103-2014-00013 |
| MDR Report Key | 3878064 |
| Report Source | 01,06,07 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-05-16 |
| Date of Event | 2014-05-15 |
| Date Mfgr Received | 2014-05-16 |
| Date Added to Maude | 2014-07-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | TWO LUDLOW PARK DR. |
| Manufacturer City | CHICOPEE MA 01022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOTHERMATES HYDROGEL BREAST PAD INTNL |
| Generic Name | BREAST PAD |
| Product Code | MGQ |
| Date Received | 2014-06-03 |
| Model Number | 9403 |
| Catalog Number | 9403 |
| Lot Number | 317806X |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | TWO LUDLOW PARK DR. CHICOPEE MA 01022 US 01022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-03 |