MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-17 for SKIN-PREP SPRAY 420200 manufactured by Smith & Nephew.
[18495229]
For approx six months, reporter has applied the same dressing to her client. She has prepared her skin the same way using skin prep spray. In 2008 while spraying skin prep on her client she inhaled at the same time. Reporter started to cough, then she lost her voice and then her breathing became labored. Her pt called 911 and the emts gave her o2 and took her to the er. She stayed in the er for 3-4 hours and was sent home. While at the hosp, she was given steroids and benadryl. She picked her car up from her client's home that night and was told to see her dr the following day.
Patient Sequence No: 1, Text Type: D, B5
[18692089]
A sample was not submitted for examination; therefore, this complaint could not be confirmed. A lot number for the product was not provided, thus a review of the mfg records, retains and product testing results cannot be performed. A search of the capa system was performed, revealing nothing pertaining to this issue. A search within the complaint system found that this was an isolated incident. The product msds states the following "high air concentration may cause mild eye, nose and throat irritation. Prolonged inhalation may cause drowsiness, headache and mild narcosis. " the root cause is for this issue is accidental inhalation of the product. The ramr file was reviewed and inhalation is listed at a frequency of one in 10 million occurrences. As this is an isolated incident and no other reports of a similar nature were found, this occurrence is within the expected frequency. Safety testing and msd's are kept on all the raw materials used in the mfr of skin prep spray. Any future complaints related to this product will be tracked and trended, and should a significant trend of this issue occur corrective action will take place at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017593-2008-00013 |
| MDR Report Key | 1272976 |
| Report Source | 05 |
| Date Received | 2008-12-17 |
| Date of Report | 2008-12-15 |
| Date of Event | 2008-11-18 |
| Date Added to Maude | 2009-01-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY MCMAHON |
| Manufacturer Street | 11775 STARKEY RD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273921261 |
| Manufacturer G1 | SMITH & NEPHEW INC., WOUND MANAGEMENT |
| Manufacturer Street | 11775 STARKEY RD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN-PREP SPRAY |
| Generic Name | NEC (BANDAGE, LIQUID, SKIN PROTECTANT) |
| Product Code | KOY |
| Date Received | 2008-12-17 |
| Model Number | 420200 |
| Catalog Number | 420200 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-12-17 |