MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-26 for ANCHOR FIX UNDERWRAP NC22001-2 manufactured by Pharmacare, Ltd.
[21023927]
After wearing the anchor fix underwrap, the pt developed some rashes. Anchor fix underwrap is a latex free product.
Patient Sequence No: 1, Text Type: D, B5
[21097539]
Na.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00005 |
| MDR Report Key | 2640046 |
| Report Source | 04 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-07-15 |
| Date Facility Aware | 2011-07-15 |
| Report Date | 2011-08-23 |
| Date Mfgr Received | 2011-07-15 |
| Date Added to Maude | 2012-07-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAN LYNCH |
| Manufacturer Street | 8100, CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | PHARMACARE, LTD |
| Manufacturer Street | 120 M004, LAD KRABANG INDUSTRIAL ESTATE, CHALONGKRUNG ROAD |
| Manufacturer City | BANGKOK |
| Manufacturer Country | TH |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR FIX UNDERWRAP |
| Generic Name | FABRIC UNDERWRAP |
| Product Code | ILH |
| Date Received | 2011-08-26 |
| Model Number | NA |
| Catalog Number | NC22001-2 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMACARE, LTD |
| Manufacturer Address | BANGKOK TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-26 |