MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-05-03 for WALGREENS UPC311917151434 220544 manufactured by Covidien/medtronic.
[44293909]
As of 05/02/2016, aso has not received returned samples from the retailer. Aso contacted the manufacturer on 04/07/2016 to inform about the complaint. Manufacturer is awaiting on returned samples.
Patient Sequence No: 1, Text Type: N, H10
[44293910]
Consumer reported that sterile pads with phmb caused her an allergic reaction, her skin became raw and she sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
[58620717]
As of 05/02/16 aso has not received returned samples from the retailer. Aso contacted the manufacturer on 04/07/2016 to inform about the complaint. Manufacturer is awaiting on returned samples. As of 10/24/2016 aso sent unused returned sample to the manufacturer for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[58620722]
Consumer reported that sterile pads with phmb caused her an allergic reaction, her skin became raw and she sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2016-00064 |
| MDR Report Key | 5624653 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-04-06 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2015-10-17 |
| Date Added to Maude | 2016-05-03 |
| 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 | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer Phone | 9413790300 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREENS |
| Generic Name | ANTIBACTERIAL GAUZE PADS 2X2 |
| Product Code | EFQ |
| Date Received | 2016-05-03 |
| Model Number | UPC311917151434 |
| Catalog Number | 220544 |
| Lot Number | 37604 |
| Device Expiration Date | 2018-07-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/MEDTRONIC |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFILED MA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |