MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-06 for LF-C2FMS-M-100 1.5X36" 100 SET 40000009 manufactured by Covidien.
[15860848]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with an abdominal belt. The customer stated that one of her patients had a reaction to one of the belts that was used while the patient was in the hospital. The reaction looked like a red rash with pustules. Medication was prescribed, nizoral 2% cream to wash the body and triamcinolone 1% cream.
Patient Sequence No: 1, Text Type: D, B5
[15974412]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681860-2013-00021 |
| MDR Report Key | 3338561 |
| Report Source | 06 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-08-23 |
| Report Date | 2013-08-23 |
| Date Reported to Mfgr | 2013-08-23 |
| Date Mfgr Received | 2013-08-23 |
| Date Added to Maude | 2013-09-17 |
| 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 | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 215 HERBERT ST. |
| Manufacturer City | GANANOQUE, ONTARIO K7G |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K7G |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LF-C2FMS-M-100 1.5X36" 100 SET |
| Generic Name | ABDOMINAL BELT |
| Product Code | FSD |
| Date Received | 2013-09-06 |
| Model Number | 40000009 |
| Catalog Number | 40000009 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HERBERT ST. GANANOQUE, ONTARIO K7G2Y7 CA K7G 2Y7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-06 |