MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-09-09 for MCKESSON 1975147 manufactured by Aspen Surgical Products, Inc..
[4938475]
We used to use the 3 m steri-strips #r1547 in bourne. These are applied to the biopsy sites of the womans breast after the procedure. We replaced this product with 19-75147, this is a mckesson product. A patient was in last week and doctor (b)(6) brought me in the room after her stereotactic biopsy showed what happens when we use the mckesson steri-strips. They disintegrate when they get wet and when she tried to remove it from her breast the strip was stringy and pulled at the biopsy site causing it to bleed more.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2014-00053 |
| MDR Report Key | 4118072 |
| Report Source | 08 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-09-09 |
| Date of Event | 2014-08-14 |
| Date Mfgr Received | 2014-08-26 |
| Date Added to Maude | 2014-09-26 |
| 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 | MCKESSON |
| Generic Name | MCKESSON WOUND CLOSURE, REINFORCED |
| Product Code | FPX |
| Date Received | 2014-09-09 |
| Model Number | 1975147 |
| Lot Number | 46490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2014-09-09 |