MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-02-18 for ASPEN SKIN CLOSURE, REINFORCED 1048NS manufactured by Aspen Surgical Products, Inc..
[4354780]
The customer stated: the steri strips are leaving blisters on the pts. Per customer: blisters occurred post-surgical but since they are the surgical center they do not see the pts after their procedures are completed. However, they were informed by the physician about the blisters. Customer had stopped using the steri-strips provided in the pack and pulling from their own stock (3m).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2014-00017 |
| MDR Report Key | 3659877 |
| Report Source | 08 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-17 |
| Date of Event | 2014-02-13 |
| Date Mfgr Received | 2014-02-13 |
| Date Added to Maude | 2014-03-06 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPEN SKIN CLOSURE, REINFORCED |
| Generic Name | SKIN CLOSURE |
| Product Code | FPX |
| Date Received | 2014-02-18 |
| Model Number | 1048NS |
| Lot Number | 34141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | CALEDONIA MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-18 |