MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-16 for SKIN PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.
[2158304]
This skin prep complaint was received post smith & nephew's remedial action (voluntary recall) to prevent an unreasonable risk of substantial harm to the public health (ref. Recall #3006760724-04-06-2011-001r). The lot of product associated with this event was not subjective to the recall noted. Adverse incident replaced insulin pump site, (b)(6) when replacing patient noticed a small point of irritation, (small as a ballpoint pen. ) progressively became worse as time went on. Went to visit the doctor to have the inflamed area checked out, and then sent to the hospital; more specifically to the emergency room to have it checked out. Doctors at the emergency room immediately planned for surgery the following day (b)(6). The portion that was swollen had become 21 by 9 cm large. When surgery took place, it continued to grow by 25 by 12 cm.
Patient Sequence No: 1, Text Type: D, B5
[9330964]
The samples were returned by the customer. The samples were not tested by the outside lab or by s&n since this lot was manufactured by s&n prior to shut down, and therefore were not subjected to the recall. Based on a historical review of this product testing of samples is not warranted at this time. The batch record related to this lot 522186 was reviewed and confirmed that the product was manufactured according to the specifications and met all the release criteria. The product was manufactured and released in march 2009. The production environment was controlled to (b)(4) adequate environmental monitoring was performed to ensure that product is manufactured under clean environment. (b)(4). There were no issues reported with this lot since it was distributed. This is the only complaint reported for this lot. There were no recalls issued by s&n for this product prior to the recall in 2011. Our medical and clinical reviews of similar complaints associated with this product have concluded that s&n product are not the root cause of this issue. Microbial testing has been added for this product prior to release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00046 |
| MDR Report Key | 2251037 |
| Report Source | 04 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-04-19 |
| Date of Event | 2011-04-19 |
| Date Mfgr Received | 2011-04-19 |
| Date Added to Maude | 2011-09-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer Phone | 7273993785 |
| Manufacturer G1 | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN PREP WIPES |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2011-09-16 |
| Model Number | 420400 |
| Lot Number | 522186 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33176 US 33176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2011-09-16 |