MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-02-21 for SKIN CLOSURES- FLEXIBLE 1975347PCS manufactured by Aspen Surgical Products, Inc..
[3170994]
Strips are producing a skin reaction recently; redness and blistering. Doctor has ruled out other causes and while not 100% positive, it is strongly suspected it is from this item. Multiple lots were mixed in one bin and all have been pulled.
Patient Sequence No: 1, Text Type: D, B5
[10522946]
Method: products received and meet specification. Results: met specifications. Conclusions: device was used with an adhesive accelerator. The device is not intended to be used with an adhesive accelerator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836161-2013-00017 |
| MDR Report Key | 2987917 |
| Report Source | 08 |
| Date Received | 2013-02-21 |
| Date of Report | 2013-02-21 |
| Date of Event | 2010-04-22 |
| Date Mfgr Received | 2010-04-22 |
| Date Added to Maude | 2013-03-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6166987100 |
| Manufacturer G1 | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN CLOSURES- FLEXIBLE |
| Generic Name | SKIN CLOSURE- FLEXIBLE |
| Product Code | FPX |
| Date Received | 2013-02-21 |
| Catalog Number | 1975347PCS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-21 |