MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-05 for 3001-1- COOL COMF PERIPAD 24/CA MH20002 MH2002 manufactured by Covidien.
[20629155]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a cold pad. The customer reports that they sent the pad home with the end user. The end user activated the pad, sat on it, and fell asleep. Upon waking up, the end user discovered that there had been a chemical spill and she had a chemical burn on her perineum. The patient reported she was prescribed silvadene cream for the burn.
Patient Sequence No: 1, Text Type: D, B5
[20825546]
Submit date: (b)(4) 2010. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219103-2010-00002 |
| MDR Report Key | 1654368 |
| Report Source | 05 |
| Date Received | 2010-04-05 |
| Date of Report | 2010-04-02 |
| Report Date | 2010-04-02 |
| Date Reported to Mfgr | 2010-04-02 |
| Date Mfgr Received | 2010-04-02 |
| Date Added to Maude | 2011-02-11 |
| 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 | 3 |
| Manufacturer Contact | RORY BLOOM, RN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524938 |
| 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 | 3001-1- COOL COMF PERIPAD 24/CA |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2010-04-05 |
| Model Number | MH20002 |
| Catalog Number | MH2002 |
| Lot Number | 935517 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| 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 | 2010-04-05 |