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 2015-11-11 for WALGREENS WOUND CLOSURE ADHESIVE STRIPS 311917143354 156744 manufactured by Aso Llc.
[30969586]
Aso/manufacturer reached out to consumer/end user on 2 occasions to request samples of the remaining device/product by return mail for investigation and testing; to date there has been no response. Device evaluated by manufacturer. Evaluation of a representative sample of the related medical device is summarized.
Patient Sequence No: 1, Text Type: N, H10
[30969587]
On (b)(6) 2015 consumer/end-user reported that the wound closure strips left a bad rash, tore the skin off, and burned the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2015-00083 |
| MDR Report Key | 5219109 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-11-11 |
| Date of Report | 2015-11-11 |
| Date Mfgr Received | 2015-09-18 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2015-11-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VP STEVE WALTER |
| 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 WOUND CLOSURE ADHESIVE STRIPS |
| Generic Name | ADHESIVE STRIPS |
| Product Code | FPX |
| Date Received | 2015-11-11 |
| Model Number | 311917143354 |
| Catalog Number | 156744 |
| Lot Number | 00031936 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASO LLC |
| Manufacturer Address | 300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-11 |